Vacancy Description
Sr Manager, Quality and Change Management
Marlborough, MA, United States
The Senior Manager, Quality and Change Management is responsible for providing leadership and strategic oversight for Global Quality Management System (QMS) activities at Hologic.
This role ensures effective governance, compliance, harmonization, and continuous improvement of key QMS processes, including Document Control, Change Control, Management Review, Quality Planning, and Management Responsibility. The position involves managing a team, driving quality initiatives, and ensuring alignment with regulatory and corporate standards.
**Knowledge**
+ In-depth understanding of quality management systems, especially in the medical device or related industry
+ Strong knowledge of applicable regulations and standards, particularly ISO13485 and 21CFR Part 820
+ Familiarity with the Hologic Corporate Quality Manual and corporate procedures
+ Awareness of international...
Marlborough, MA, United States
The Senior Manager, Quality and Change Management is responsible for providing leadership and strategic oversight for Global Quality Management System (QMS) activities at Hologic.
This role ensures effective governance, compliance, harmonization, and continuous improvement of key QMS processes, including Document Control, Change Control, Management Review, Quality Planning, and Management Responsibility. The position involves managing a team, driving quality initiatives, and ensuring alignment with regulatory and corporate standards.
**Knowledge**
+ In-depth understanding of quality management systems, especially in the medical device or related industry
+ Strong knowledge of applicable regulations and standards, particularly ISO13485 and 21CFR Part 820
+ Familiarity with the Hologic Corporate Quality Manual and corporate procedures
+ Awareness of international...
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