Manager of Quality Engineering & RA
Mount Vernon, NY
Manager of Quality Engineering - Mount Vernon, NY
The Company: Innovative Products. Empowering Employees. Impacting Patient Lives.
Would you like sit on the Senior Leadership Team for a Medical Device company whose innovative products are known as the “Gold Standard” in their industry? This growing client hast has retained us to identify their next Quality Engineering Manager.
*******IMMEDIATE INTERVIEWS ARE BEING SCHEDULED FOR NEXT THURSDAY & FRIDAY*******
The Challenge: We need a Quality Engineering & RA Manager who will take ownership for the entire QMS while overseeing a small team. You must be self-driven, able to provide the executive strategy, and then love of being hands-on in the implementation and continuous improvement of all initiatives. Ensuring appropriate documentation, files, and having an ongoing updated QMS is absolutely pivotal for this role.
Location: Mount Vernon, NY
Compensation: Competitive Base Salary with Bonus, Benefits, and much more!
- MUST have experience overseeing QA/QE efforts for a manufacturing facility within the Medical Device, Biotech.
- MUST have functioned as “FDA Lead” in Audit experiences. RA experience
- Authored a 510K and/or Tech File Submission
- MUST function as the company subject matter expert for all documentation, appropriate files, validation, processes, and compliance for the facility
- MUST have expertise in 21CFR820, MDD, ISO - 13485, ISO – 14971, MDSAP
- MUST have a BS – IDEALLY in Engineering or related scientific fields
If you can provide me with Proof Of Performance in the above mentioned areas please apply
Sponsorship is not available.
Submit resume to Paula Morisey email@example.com
Research & Recruitment Specialist
Paula joined the Morisey-Dart Group in August of 2017. She is the firm’s research and recruitment specialist for the medical device and precision machining/manufacturing teams. She is responsible for sourcing and recruiting, lead generation, internet research and various other responsibilities within both the medical device and precision machining industries.
With 25 years at Xerox Corporation in New York, Paula had a prosperous and noteworthy career where she excelled during her tenure. She brings her vast knowledge and expertise in procurement, supply chain, contract administration and project management to the firm. She is a creative and natural problem-solver with proven success in developing and implementing new procedures and processes as well as integrating newly acquired subsidiaries.
Now, she’s using her expertise to build a network of solid relationships in the medical device and precision machining industries that help hiring managers find the top talent they need to improve their organizations.
Paula is Lean Six Sigma certified (Green Belt), has a Master of Science in business management and a Bachelor of Science in education.