- Insight Global (Murrysville, PA)
- …820 ( Quality System Regulation) and ISO 13485 (Medical devices Quality management systems ). 1. How do you ensure that CAPA activities meet FDA and ISO ... CAPA activities from issue identification closure, project manage CAPA activities, ensuring the quality of ...3+ years in a highly regulated environment as an engineer that has done CAPA 's as part… more
- Philips (Cambridge, MA)
- …or a related technical discipline. Certified Six Sigma Green/Black Belt or ASQ Certified Quality Engineer (CQE) desired. + You must be able to successfully ... The Senior Quality Manager- CAPA will play a critical...and cross-functional collaboration abilities. + You're experienced with electronic quality management systems (QMS). + You have… more
- Capgemini (Nashville, TN)
- … Quality , or Life Sciences related areas. *4-6 years of experience in CAPA management, quality assurance, or regulatory compliance. *Strong knowledge of root ... *Familiarity with regulatory compliance tools, such as risk management software and CAPA management systems . **Life at Capgemini** Capgemini supports all aspects… more
- Astellas Pharma (Westborough, MA)
- …compliance. + Continuous Improvement: Proactively seek opportunities for improving investigation processes, CAPA systems , and the overall quality system ... on compliance and continuous improvement. **Preferred:** + ASQ certifications (eg, certified quality engineer , quality auditor, quality professional,… more
- Abbott (Columbus, OH)
- …and agency regulations. **WHAT YOU'LL DO** + Management and development of Quality Systems Engineers. + Administer and lead Corrective/Preventive Action program ... + Provide expert level guidance and direction of the CAPA systems Body-of-Knowledge. + Assess resource needs...Six Sigma Black Belt strongly preferred. + ASQ Certified Quality Engineer strongly preferred. + Industry certification… more
- Pentax Medical (Montvale, NJ)
- …Thorough understanding of CAPA processes, Product and Process Change Management, and Quality Systems + Six sigma certified + Strong ability to manage ... imaging devices and solutions to the global medical community. Position Opening: Senior Quality Engineer Why JOIN Us? We are an established medical device… more
- Actalent (Irvine, CA)
- Quality Engineer (TrackWise) Responsibilities + Ensure compliance to CAPA processes and procedures. + Review and approve NC and CAPAs for completeness, ... agencies (FDA, MoH, TUV, etc.). + Ability to support Quality Systems (audits, management review, quality...engineering within the medical device industry. + ASQ Certified Quality Engineer (CQE) or equivalent preferred. +… more
- Integra LifeSciences (Mansfield, MA)
- …required. Previous experience managing CAPA process desired. + Previous experience providing Quality Systems and CAPA training required. + Quality ... outcomes and set new standards of care. The Senior Quality Engineer I is responsible for supporting...lieu of a degree. + Strong knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and… more
- American Packaging (Rochester, NY)
- Quality Systems Engineer Rochester, NY (http://maps.google.com/maps?q=Engineered,+Laminations+and+Co+Rochester+NY+USA+14613) Description At American ... for audits and customer requests for information (RFI). + CAPA Management: Produce effective corrective action responses for audit...field. + Minimum of 3-5 years of experience in quality systems management, preferably in the packaging… more
- Teleflex (Morrisville, NC)
- Senior Quality Engineer , Quality Systems (15 month contract role) **Date:** Apr 6, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex ... including but not limited to Change Management, Training, NC, CAPA , Quality Data Analysis Review (QDAR), Auditing,...is as efficient and effective, as possible. * Provide Quality Systems support to all areas of… more
- Integra LifeSciences (Cincinnati, OH)
- …+ Certified Quality Engineer , preferred. + Working knowledge of Quality System elements of CAPA , Control of Nonconforming Product, Change Control, and ... procedures, demonstrated understanding of system documentation. + Experience with measurement systems and statistical techniques to support Quality Control is… more
- Meta (Burlingame, CA)
- …and/or in software as a medical device (SaMD). **Required Skills:** Medical Devices, Quality Management Systems Engineer Responsibilities: 1. Identifies and ... 3. Promotes quality assurance, process controls, and Corrective Action/Preventive Action ( CAPA ) systems designed to meet or exceed internal and external… more
- Integra LifeSciences (Plainsboro, NJ)
- …or pharmaceutical manufacturing. + Demonstrates knowledge of investigations, root cause analysis, quality systems , the CAPA system and technical writing. ... patient outcomes and set new standards of care. The ** Quality Assurance Engineer II** will provide ...participate in problem solving teams, and participate from a Quality Engineering & Quality Systems … more
- Caldera Medical (Westlake Village, CA)
- Sr. Quality Engineer Caldera Medical's Mission - To Improve the Quality of Life for Women! Message from the Hiring Manager: The Quality Engineer ... microbiological procedures (sterilization, bioburden, residuals & environmental monitoring). The Sr. Quality Engineer is responsible for assisting with the… more
- 3D Systems, Inc. (Littleton, CO)
- …3D Systems facility in Littleton, Colorado seeks an exceptional Intermediate Quality Engineer to ensure excellence in the additive manufacturing of medical ... medical solutions. The successful candidate will implement and maintain rigorous quality systems that meet regulatory requirements while continuously driving… more
- Hubbell Power Systems (Leeds, AL)
- …Company: Hubbell Incorporated Job Overview The Quality Engineer will provide Quality Assurance, Quality Systems , and Supplier Quality support for ... Quality Engineer - Leeds, AL Apply...+ Support New Product Development activity including PFMEA, DFMEA, Quality Planning, Measurement Systems design and deployment… more
- Meta (Burlingame, CA)
- …medical device (SaMD) in product core teams. **Required Skills:** Medical Devices, Quality Management Systems Engineer Responsibilities: 1. Leverage ... and record keeping practices 15. Regulatory Affairs Certification or Certified Quality Engineer /Certified Quality Manager certification 16. Experience… more
- Parker Hannifin Corporation (Irvine, CA)
- Senior Quality Engineer , Fluid Systems Division Location : IRVINE, CA, United States Job Family : Quality Job Type : Regular Posted : Apr 23, 2025 Job ID ... of products, processes, and production equipment. . Develops and establishes advanced quality systems and procedures, inspection plans, quality performance… more
- Hubbell Power Systems (Wadsworth, OH)
- …Hubbell Incorporated Job Overview The Associate Quality Engineer will provide Quality Assurance, Quality Systems , and Supplier Quality support ... Associate Quality Engineer Apply now " Date:...as assigned by assigned supervisor. + Management of Calibration Systems , Tooling, and Instrumentation + Lead and/or participate in… more
- Abbott (Minnetonka, MN)
- …people to restore their health and get on with their lives. As the ** Quality Engineer II** , you will support sustainability of commercially released product ... Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed...initiatives as identified by management and in support of Quality + Management Systems (QMS), Environmental Management… more
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