Location: Chicago, IL
Company: F.H. Paschen
to requirements of the company quality program and the project contract requirements. Schedule and coordinate inspection and testing for work activities with Production Team Members. Supervise, monitor activities, and review reports, performed by Independent Testing Agencies.
Generate Non-Conformance Report for work that is not compliant with the contract requirements and maintain a Non-conformance Log. Coordinate and perform receiving inspections for contract compliance on delivered materials, products and equipment to be permanently installed in the work. Generate Quality Activity Reports for construction activities performed by Subcontractor or self-performed work. Work with suppliers,
fabricators and manufactures to ensure quality is being performed in accordance with contract specifications. And all other assigned quality field responsibilities.
Administrative Responsibilities: Develop understanding/working knowledge of company quality program and applicable industry standards. Participate with Quality Manager with internal/external quality audits; provide input for improving quality control procedures, developing new procedures and quality standards. Assist Quality Manager with review of subcontractor quality control plans when needed. Inform staff and subcontractors on company quality requirements and specific project contract quality requirements. Assist Superintendent,
Project Managers and Project Engineers in resolving non-conformance issues.
Assist Project Team with Procurement of Independent Testing Agencies and Engineering Consulting Companies to perform work for quality related activities and issues. Develop understanding of project contract documentation, requirements and specifications. Review Invoices for Quality Work performed by Independent Testing Agencies and Engineering Consulting Companies and recommend payment to Project Manager. Review all quality documents from Independent Testing Agencies, Subcontractors, and Engineering Consulting Companies for accuracy and statement of conformance. Maintain quality document management system.
Attend weekly owner progress meetings when required. Attend weekly subcontractor meetings when required. Participate in the company three phases of construction quality control program.
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.
and client support teams by designing tests for ongoing projects. The analyst with consult with the QA lead to resolve quality, production, and efficiency problems. This role reports directly to the Director of Quality Assurance in our Enterprise Operations team and is a full-time salaried position.
What You Will Do: Coordinate with team to establish an automation QA test suite Record, evaluation and document results and compare to expected results. Prepare or maintain technical files as necessary to obtain and sustain product approval. Generate historical analysis data of test results for production and quality process. Develop and document training plans based on regulatory, customer,
and company requirements and specifications. Write technical reports or documentation, such as deviation reports and testing protocols. Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, and protocols.
Perform Quality Assurance review and approval of finished production batch records. Assign QA release status and disposition to approved finished products. Generate metrics that reflect the improvements of the batch record review process Issuance, review and approval of Production and Development Batch Records Review and approval of Standard Operating Procedures, Specifications, Deviation Reports, Change
Controls, OOS's/OOT's and Test Methods Performs additional tasks requested by supervisor and manager Update and maintain QA database for retrieval of reports.
Maintains accurate records of controlled document files and test records in a timely manner. What Spider Rock Is Looking For: 4-year college degree in Computer Science, Mathematics, Business, or related discipline or equivalent work experience At least 5-7 years in a QA or similar role 5-7 years of technical experience working on a testing framework Experience testing web Apps or financial trading systems a plus SQL (Any DB Automation), node. js, Rest API, Java, Selenium, python, C++, C# Familiarity with Agile methodology Attention to detail and strong organizational skills.
Test automation skills Knowledge of SQL, Selenium a plus. Strong communication skills and ability to work directly with clients, teammates, and work with technical cloud initiatives. Ability to work independently and in a team setting. Work in a high energy environment and takes ownership of tasks. Local candidates are preferred Here's What to Expect: Highly competitive pay, benefits and bonus structure Dynamic work environment: Office First, Hybrid, or Remote First Work with high-caliber and innovative professionals Access to unlimited snacks and beverages in our lounge area State of the art office 401K plan and match Progressive time-off benefits Gym membership at our building fitness center on our floor Divvy bike access A fun and collaborative environment Spider Rock is an Equal Opportunity Employer Job Posted by Applicant Pro
cultures. The position requires self-motivation and the capacity to work independently. Must have excellent communication abilities and basic computer skills. The job often requires a great deal of walking around client sites, may include climbing stairs or ladders, and may require lifting up to 25 pounds.
This is a part-time position with no company benefits. High School Diploma or GED required. Some college courses in Chemistry or Biology are a plus. A valid driver's license and an acceptable driving record for at least two years are required. If interested, please submit your resume highlighting your experience and how it directly applies to the above requirements. Phigenics LLC is
an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, interaction, marital status, veteran status, interactionual orientation, arrest record, or any other characteristic protected by applicable federal, state or local laws.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Job Posted by Applicant Pro
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.
