- Cardinal Health (Indianapolis, IN)
- …+ Understands technical/release product issues and evaluate their potential impact on product quality and compliance + Champion Quality , GMP compliance ... network across business and functional units to achieve positive outcomes. + Assists Quality Management with FDA and other regulatory agency activities. +… more
- Medtronic (Northridge, CA)
- …meaningful innovations. The Sr Program Manager - Development Process & Compliance will be responsible to lead/co-lead the Product Development processes encompassing ... on navigating through product development activities through the product lifecycle ensuring compliance with regulations and standards. + This role is critical to… more
- DEKA Research & Development (Manchester, NH)
- …environment, working hand-in-hand with cross-functional teams to ensure the highest standards of quality and compliance . Key responsibilities as a Quality ... and support QMS compliance . + Ensure ongoing compliance with FDA 21 CFR Part 820...identify and implement system improvements. + Review and approve quality records for accuracy and compliance . +… more
- Medtronic (Northridge, CA)
- …Systems globally. This role supports quality management systems (QMS) to ensure compliance with FDA , ISO, and other applicable standards. This role is ... innovation in a more connected, compassionate world. **A Day in the Life** The Quality Systems Business Analyst will be working across the Diabetes Quality … more
- Envista Holdings Corporation (Pomona, CA)
- …QUALIFICATIONS:** + Experience with statistical software (Minitab, JMP, etc.) + Certified Quality Engineer preferred. + FDA Quality System Regulation ... claims and target markets early in the product development lifecycle. + Performs quality engineering reviews of design documentation for compliance with stated… more
- BD (Becton, Dickinson and Company) (Vernon Hills, IL)
- **Job Description Summary** As directed by the Quality Manager, the Quality System Specialist III is accountable for support of the continued development, ... improvement and implementation of the Quality Systems. This position actively participates in ...customer complaints, investigations and communications for validity and assures compliance with policies and procedures. + Development of Complaint… more
- Kelly Services (Tualatin, OR)
- …Oregon. This position is responsible for ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and supporting quality activities across manufacturing and ... with R&D, Manufacturing, and Regulatory teams to ensure product quality and compliance . **Qualifications** + Bachelor's degree...quality . + Strong knowledge of ISO 13485 and FDA 21 CFR Part 820; EU MDR knowledge preferred.… more
- Abbott (Plymouth, MN)
- …the chance to assure products, processes, and quality records conform to quality standards and establish compliance within Abbott's quality system on ... generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Quality Engineer II - 2nd shift** **Working at Abbott** At Abbott, you can… more
- Hologic (Newark, DE)
- …fast-paced, regulated environment. + Demonstrates urgency and accountability in resolving quality issues and ensuring compliance . **Experience** + Bachelor's ... is highly beneficial. + Demonstrated experience in quality assurance, quality improvement methodologies, and regulatory compliance . + Proven ability to… more
- DEKA Research & Development (Manchester, NH)
- …critical thinking and analysis to determine the best approach and provide guidance on QMS, FDA Part 820, and ISO 13485 compliance to design team members + Review ... and approve quality records to ensure accuracy, completeness, and ...Visio skills Nice skills to have: + Knowledge of FDA 's Quality System Regulation + Knowledge of… more