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 ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance