Senior Manager Quality Operations
Summary: Seeking a Senior Manager for Quality Operations to oversee site-level Quality System compliance and manage a team in the medical device industry.
Requirements:
- Bachelor's Degree
- 10 years experience in the Medical Device Industry
- 5+ years at Quality Manager Level
- Experience with QMS Processes for ISO 13485, 21 CFR 820, MDR
- Proficiency in MS Word, Excel, Access
Responsibilities:
- Manage site-level Quality System compliance with regulatory requirements
- Act as site Quality System Deputy Management Representative
- Oversee product testing and release processes
- Implement timely evaluations and investigations for product safety and efficacy
- Manage activities related to Internal and External QMS Audits
- Ensure effective Corrective and Preventive Action system
- Maintain employee training process and Document Control process
- Promote Environmental, Health, and Safety initiatives
Pay Details: $175,000.00 to $185,000.00 per hour
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
- San Francisco Fair Chance Ordinance
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