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Qms Manager Jobs
Company | Agilent Technologies |
Address | Atlanta, GA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-06-06 |
Posted at | 11 months ago |
- Oversee preparation and provide direction on the content of Quality Management Review (QMR) in alignment with global standards and initiatives.
- Oversee establishment and analysis of quality metrics (KPIs) to assess the effectiveness of the QMS and drive improvements.
- Support audit preparedness to comply with authority, notify bodies, customer, and internal audits.
- Ensure implementation of current applicable regulatory requirements (In Vitro Diagnostic medical devices Regulation (IVDR) (EU) 2017/746, ISO13485, FDA CFR 21 Part 820) as well as evaluation of new/changed requirements.
- Develop team capabilities and create standard work with the goal of establishing a center of excellence for QMS process management within DGG.
- Represent DGG in global QMS harmonization and IT system projects and coordinate implementation activities across DGG.
- Provide leadership to QMS process owners and develop and implement improvement programs at the site, division, and DGG level.
- Act as the Training process owner and support implementation of a global Learning Management System (LMS).
- Strong knowledge and understanding of standards and regulations: ISO 14971:2019, Regulation (EU) 2017/746, FDA CFR 21 Part 820, ISO 13485
- Strong analytical skills with focus on finding the right solutions in compliance with the regulations.
- Minimum of 7 years supervisory experience (managing direct reports), including hiring, training, coaching and performance management activities
- Bachelor or Master’s degree in Engineering or Scientific/Technical discipline
- Minimum of 7 years professional experience in Quality in the medical device industry
- Direct experience in managing QMS processes under above regulations
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