Manager, Quality Operations (Onsite)
Insulet Corporation
Manager, Quality Operations (Onsite)
The Quality Operations Manager will manage site-level Quality System compliance at the Waalwijk facility, ensuring full compliance with US FDA, ISO 13485, MDSAP/MDR and other regulatory requirements. This role focuses on QC testing, documentation review, product release, and serves as Site Quality System Deputy Management Representative and Safety Officer.
Manager, Quality Operations (Onsite)
The Quality Operations Manager will manage site-level Quality System compliance at the Waalwijk facility, ensuring full compliance with US FDA, ISO 13485, MDSAP/MDR and other regulatory requirements. This role focuses on QC testing, documentation review, product release, and serves as Site Quality System Deputy Management Representative and Safety Officer.
Salary
Core Qualifications
Technical (Must-have)
Soft Skills
Key Responsibilities
- Establishes, maintains, and promotes a strategy for compliance with quality objectives.
- Ensure product is tested and released in accordance with company policies and procedures.
- Ensures timely and accurate evaluations and investigations.
- Manages Internal and External QMS Audits.
- Establishes and promotes a culture of compliance and quality.
- Establishes and maintains a robust employee training process.
- Manage direct reports to ensure timely completion of activities.
- Establish and maintain an effective Document Control process.
- Identify process improvement opportunities.
- Participate in cross-functional and cross-location activities.
- Support Global Product Monitoring lab.
- Engage in Environmental, Health, and Safety initiatives.
- Maintain infrastructure, process equipment, and monitoring equipment.
- Support good relationship with suppliers/landlord.