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.
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.
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.
