QA/RA Manager
Medical Device Product Development
Long Island NY
Highly regarded global medical devices company seeks a Sr. Quality Manager to lead quality and regulatory activities at the company's manufacturing site on Long Island, NY. The Sr. Quality Manager will have all stage gate approval responsibilities, including all technical files, 510 (k) submissions, design history files, product specifications, labeling materials and product registrations.
This industry leader has many new products in the pipeline and offers great career growth opportunities across its many divisions, both domestic and international.
Job Requirements
- Bachelor's degree in engineering or scientific discipline
- 5+ years of quality experience in medical device manufacturing
- ASQ or CQE certification preferred
- Six Sigma/Lean experience; certification preferred
- Regulatory experience including 510K preparation and submission
- Experience with design history files, technical files and product labeling
- Strong working knowledge of FDA requirements, including ISO 13485, and European standards
- Experience assessing regulatory status of existing products with the preparation of applicable action plans to solve gap issues
- Experience preparing regulatory status reports of multiple products
- Excellent analytical and communications skills, both oral and written
- Experience working with or leading cross functional teams
- Proficiency with Microsoft Word and Excel
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