Location: Waukegan, IL
process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control files, and CE technical files. MAJOR RESPONSIBILITIES: Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
Design complex experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes. Design and perform experimental product testing and analysis to maintain quality
levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
Direct and collaborate with supplier representatives on quality problems, ensure that effective corrective actions are implemented (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications. Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files. Responsible for building appropriate product documentation (e. g. Device Master Records) in compliance with applicable
regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc.
as required. Coordinate product testing with internal and external laboratories as required. Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records. Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA). May train and coach team members and Medline employees on appropriate processes and best practices.
Act as Quality lead in the absence of Quality Management. Education Typically requires a Bachelor's degree in Engineering, Science, Math or other related technical field. Work Experience At least 4 years of experience in the Quality or Engineering. Experience applying knowledge of government and industry quality assurance codes and standards (e. g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards). Knowledge / Skills / Abilities Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation is necessary.
Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects. Experience problem solving, overcoming obstacles and reaching a positive and successful solution through mathematical or systematic operations. Experience leading a team to accomplish cross-functional goals. Experience using MS Office Suite products (Word, Excel, Power Point, and Outlook). Advanced Skill Level in Microsoft Excel (for example: Pivot tables & pivot reporting, conditional formatting, tables, formulas, charting).
Position requires up to 15% travel. PREFERRED JOB REQUIREMENTS At least 5 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role. Knowledge of advanced Six Sigma/Lean concepts.
analyze all press side job requirements such as copy and color confirmation, adhesive thickness, silicone requirements, etc. 2. Collect, retain and test finished and developmental materials for required quality levels and adherence to predetermined specifications.
3. Perform a variety of test procedures involving collecting test samples, analyzing data, and writing up test reports. 4. Participate in new product development activities as directed and make recommendations. 5. Collect, organize, store, and record all retains and job checks. 6. Requisition department supplies as needed. Perform other related duties as assigned. Requirements? High School Diploma or equivalent? Minimum 1-year
Quality Control experience in manufacturing? Use a personal computer, mechanical and electronic readout test equipment, laboratory oven, electronic scale, and miscellaneous laboratory equipment?
Be proficient in reading spec sheets and diagrams? Detail oriented with strong organizational skills and ability to work in a team-oriented environment as well as work independently on projects? Computer proficiency in Word and Excel required We offer a competitive salary and benefits program, including health and wellness benefits, paid time off, life insurance, dental, vision, long-term disability coverage, profit sharing, and a 401k plan. We are proud of our innovation and customization abilities.
and device an efficient test strategy and test plan. Ability to backss and understand complex software specifications and develop test cases and conduct thorough testing to identify defects. Ability to collaborate effectively with the scrum team to understand project requirements and timelines.
Expert in performing various types of testing, including but not limited to backend data validation, smoke testing, end to end testing, performance/stress testing and regression testing. Experience in developing risk mitigation strategies as part of overall testing process. Experience performing post migration smoke testing. Strong documentation skills with the ability to create clear and
concise test plans. Document and track defects in Jira. Ability to effectively communicate issues and collaborate with cross-functional teams. Strong knowledge of Agile Methodology and SDLC.
Provide feedback to improve the software testing process and contribute to continuous improvement efforts. Job Requirements At least 5 years of experience in designing and executing test cases. Experience working in Agile/Scrum teams. Experience writing SQL Queries Experience working with Jira and Test Management tool Zephyr. Understanding of Service-oriented architecture, testing web services using SOAP Or Postman Knowledge on test automation tool UFT is a Plus Must be self-motivated and independent
thinker. A team player who has no difficulty in challenging the team to think differently.
More About Medline: Medline is the largest privately held manufacturer and distributor of healthcare supplies in the United States, providing more than 550,000 products that serve the entire continuum of care. Our innovative products and programs can be found in most hospitals, extended-care facilities, surgery centers, physician offices, home care dealers, home health agencies and retail outlets. Founded in 1910, Medline has grown from a small manufacturer of aprons, surgical gowns and uniforms to a thriving $20 billion global enterprise because of our dedicated people, entrepreneurial spirit and honest values.
Again named one of the country's " Best and Brightest Companies to Work For, " and once again named to Chicago Tribune's Top Workplaces, Medline has experienced fifty-plus years of consecutive annual growth, and is headquartered in Northfield, IL. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, interactionual orientation, gender identity or expression, protected veteran status, disability/ handicap status or any other legally protected characteristic.
and finished product inspections, and support the QA team in product testing, documentation, and vendor qualification activities. MAJOR RESPONSIBILITIES: Investigate customer/sales force complaints and assure complaints are investigated accurately and closed in a reasonable amount of time.
Issue replacements, credits, or RGA's as required for complaint resolution. Notify sales reps/customers regarding the results of the investigation. Run monthly or quarterly complaint trend reports per SOP. Coordinate stock checks and rework of product as required in response to complaints. Identify appropriate actions required to prevent further complaints. Initiate manufacturing and supplier corrective
action reports and follow up to ensure corrective actions are implemented. Coordinate or perform inspections of new products or products from new vendor at branches and factories.
Responsible for building appropriate product documentation (e. g. Device Master Records) in compliance with applicable regulations and to support Design Control and Risk Management activities. Create and maintain inspection procedures. Education Typically requires a Bachelor's degree in Engineering, Science, Math or other related technical field. Knowledge / Skills / Abilities Experience in processing all relevant details, understanding and prioritizing their importance, and drawing clear and concise conclusions.
Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations. Experience using MS Office Suite products (Word, Excel, Power Point, Outlook). Position requires up to 10% travel.
process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control files, and CE technical files. MAJOR RESPONSIBILITIES: Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes. Design and perform experimental product testing and analysis to maintain quality levels
and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications. Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files. Responsible for building appropriate product documentation (e. g. Device Master Records) in compliance with applicable regulations. Work with
Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc.
as required. Coordinate product testing with internal and external laboratories as required. Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records. Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA). COVID-19 Vaccination Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19.
This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law. Education Typically requires a Bachelor's degree in Engineering, Science, Math or other related technical field. Work Experience At least 2 years of experience in the Quality or Engineering. Knowledge / Skills / Abilities Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects. Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations. Experience using MS Office Suite products (Word, Excel, Power Point, Outlook ). Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting) Working knowledge of government and industry quality assurance codes and standards (e.
g. 21 CFR 820, ISO13485). Position requires up to 15% travel. PREFERRED JOB REQUIREMENTS At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.
displays, touch technology and motion sensing to support a range of industries including Healthcare, Automotive and Military. With headquarters just outside of Chicago, and multiple state-of-the-art facilities around the world, Grayhill has the engineering expertise and vertical integration to deliver standard and customized solutions quickly and cost-effectively.
Are You Ready to Grow With Us? Summary: Performs quality functions within the components team and serves as liaison to customers, suppliers as well as the internal Corporate Quality team. Essential Duties and Responsibilities include the following. Other duties may be assigned. Work alongside the Grayhill quality department
in compliance with all Grayhill quality requirements and processes, ensuring that product group activities meets or exceeds both the internal corporate quality requirements and the customer quality requirements.
Manage the key customer warranty claim systems with timely responses. Analyze warranty claim data and report on opportunities for improvement to the business unit. Prepare reports to communicate involvement and results of quality assurance activities. Lead the product groups' CCA process with timely and appropriate actions using 8D methodologies. Analyze CCA data and report on opportunities for improvement to the business unit. Lead the audit inspection of Component Division Production
Orders and Toolroom piece parts. Manage military A&B testing requirement process.
Manage special customer testing and review customer prints pertaining to testing. Coordinate efforts with Corporate Quality Lab. Maintain quality records for customer review and supply special Certificate of Conformance and/or testing results as required. Coordinate special customer testing with Corporate Quality Lab and Planners. Manage the Internal Corrective Action Request (ICA) process: initiate; review; contain; notify; analyze and implement customer corrective action. Serve as an internal auditor, auditing facilities as required. When required, obtain from Sales customer First Article requirements.
Review, interpret and ensure requirements are understood and met. Maintain records and have available for customer review. Design and implement quality training programs for Plant. Review, implement and maintain ISO standards as related to training and production quality. Participate in monthly quality meetings and in internal audits as assigned. Education and Experience: Bachelor's degree (B. S. ) Minimum of two years of applicable experience; or equivalent combination of education and experience Preferred Skills/Experience: Excellent communication skills with the ability to effectively work with all levels within the organization Strong intrapersonal skills - ability to thrive in a team oriented, creative, and collaborative environment.
Hands on experience working in manufacturing preferred. Experience with manufacturing process such as plastic injection molding, rubber molding, machining, or assembly. Experience working with customers and/or suppliers What we have to offer: You will be at the forefront of challenging work. We solve complex problems with innovative solutions across all teams and in all roles. There is purpose in our work! Comprehensive Health Insurance; medical, dental, prescription, and vision starting on day one.
Generous Paid Time Off 401(K) match up to 4% of salary Hybrid work model allowing 4 days a month remote Collaboration Space featuring ping pong, foosball, board games, and more. Company paid holidays Optional gap insurance coverages Company paid disability and basic group life 24/7 Employee Assistance Program Catered company events - to pause and celebrate the wins! We value diversity and inclusion. We are an equal opportunity employer and we do not discriminate on the basis of gender, color, race, religion, marital status, interactionual orientation, or national origin. Job Posted by Applicant Pro
process and test method validation within Design Control and Software Development Life Cycle {SDLC). Reviews and approves software lifecycle deliverables. Directly influences project direction and scope, guides product development teams through design validation and regulatory compliance and assures robust product vs.
customer requirements. Applies established quality and engineering methods to the investigation and solution of software quality problems. Supports CAPA {Corrective Action Preventive Action) and FCA (Field Corrective Action) activities as required. Participates, through the creation and review of improvements of software development, software processes, and documentation
processes. Supports supplier qualification and maintenance activities. Performs SCAR {Supplier Corrective Action), and process deviation activities. Participate in internal and external (i.
e. FDA, Registrar, Notified Bodies) audits. Understands and backsses the impact of a change on the safety and efficacy of a software product, device, process performance, and internal/external customer expectations worldwide. Participates in Risk Management activities. backsses internal and external risks associated with specific actions, quantifies risks, seeks input from others, and identifies actions to limit the exposure of the division. Supports and provides oversight to non-product software lifecycle
activities including review and backssment of software activities {suppler evaluations, validation, lifecycle deliverable documents) to ensure compliance with applicable procedures, standards, and regulatory requirements.
Participates in multi-site and business wide software lifecycle activities to accomplish quality system objectives. Investigates and analyzes impact of failure within and across product lines. Uses technical, compliance, product, and process knowledge to assist in identifying preventative actions. Able to assure effectiveness of actions are taken to prevent reoccurrence. Requirements: 4-year degree (Bachelor? s Degree) in a scientific or technical discipline preferred or 10+ years of experience in a related field.
1-3 years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes. Excellent communication skills, problem solving capability and attention to detail is critical. Knowledge of regulations and standards affecting software development and overall design control for medical devices. Experience in applying quality regulations and standards {e. g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, Cybersecurity- ISO 27001), and working knowledge of current and applicable GMP regulations is required.
Use of analytical skills and ability to organize work in a logical and thorough manner. Capable of analyzing data to support the development of strategies to effectively manage, enhance, mitigate, and/or resolve potential issues. Challenges data adequacy based on experimental design concepts. Recognizes when issues may have an impact on areas outside of their immediate area of responsibility. Highlights issues in a timely manner and presents possible resolutions. Seeks additional information when problem is beyond area of personal expertise. Experience in reviewing, and executing validation and change control documents, authoring SOPs, Protocols {IQ, OQ, PQ) of Process Control Systems
that values hard work, integrity and ethics. Professional Plastics is currently offering great career opportunities. We are interested in hiring motivated professionals who share our core values and desire to be part of a dynamic team. Professional Plastics is an equal opportunity employer and offers competitive pay and benefits.
Benefits Package: NEW Daily Pay - Provides early access to earned wages Medical Dental Vision Flexible Spending Account 401K Plan Basic Life and AD&D Voluntary Life Insurance Long Term Disability Employee Assistance Program Vacation Sick Leave Paid Holidays Position Summary: The Quality Control Inspector is responsible for conducting both quality assurance, quality
control and inspection activities. Assists in the development, improvement and implementation of current and new processes and procedures. Essential Duties and Responsibilities: Include the following, as well as other duties may be assigned.
Organize, prepare and perform internal audits for the branch per ISO 9001/AS9100 requirements Calibration Program – Equipment calibration, periodic verification. Corrective Actions – Assign, investigate and respond to opportunities for improvement. Certification of Conformance – Complete and submit supporting documentation as required. Equipment Maintenance – Scheduling and recording equipment maintenance. All Inspection activities – First Article,
In-Process and Final. RMAs, Scrap and Internal Rejects – Analyze all products and processes in order to identify root causes and problem resolution.
Implement and manage all calibration activities through formal programs. Documentation – Complete both internal and customer related documentation as required. Other duties and assignments as required. Experience: Experience in both quality assurance and quality control activities. Ability to read and interpret prints drawings and customer contractual requirements. Manufacturing and Inspection background experience preferred. Equal Opportunity Employer : Disability/Veteran Job Type : Full-time
Health, dental, vision A health savings account (HSA) Life insurance Employer-paid short-term disability A 403(b) retirement plan with up to 5% company match Employee assistance program Paid time off (PTO), holidays, and parental leave Lunches, employee appreciation, and annual retreats Continuing education If you are excited about the opportunity to contribute to our team's success and earn a competitive wage , then we would love to hear from you!
WHO ARE WE? AN INTRODUCTION We are a faith-based organization, founded upon the social justice heritage of the United Church of Christ. Since our founding in 1895, we have grown to be one of Southern Illinois' leaders in providing emotional
and mental health services for every stage of youth and family development. Our mission is to enable all people, young and old alike, to realize the wholeness of life that God intends.
Our team of professionals is energized daily because they have the opportunity to bring positive change to someone's life. In fact, " changing lives" is in everyone's job description. We also offer competitive pay, excellent benefits, and a positive work culture. A DAY IN THE LIFE OF A QUALITY ASSURANCE SPECIALIST You focus on identifying and addressing missed opportunities related to quality and compliance. This includes creating comprehensive plans to monitor and improve processes, providing
recommendations and support, and coordinating activities during external program reviews.
Your active involvement in accreditation processes such as COA, DCFS, and Medicaid recertification requires you to review procedures and data submitted by the Quality Improvement team. You implement administrative systems to enhance efficiency, lead targeted projects based on data analysis, and provide leadership and guidance in implementing performance improvement activities. Moreover, you train and staff support, lead the onboarding process, identify trends and gaps in services, and conduct regular meetings with staff. Your role also involves strategic planning, acting as a bridge between program staff and leadership.
You report quality and compliance concerns and collaborate with department directors to develop improvement plans. Additionally, you provide support to the Critical Incident Support Team, contribute to the creation and quarterly review of the Annual Risk Review, and prioritize QI requests submitted by agency staff. You demonstrate a strong commitment to achieving and maintaining quality goals and objectives throughout the organization. QUALIFICATIONS A Bachelor's degree in human service, business, or a related field; OR Certification in Continuous Quality Improvement or Green Belt in Six Sigma 3+ years of experience performing quality improvement duties 2+ years of experience leading and managing QI project teams
Six Sigma experience and a willingness to obtain a green belt if one does not currently possess
21+ years of age.
A valid driver's license and proof of automobile insurance ARE YOU READY TO JOIN OUR TEAM? If you're passionate and driven, we want to hear from you! Apply now and take the first step toward a fulfilling career! Job Posted by Applicant Pro
