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- Offer technical mentorship to Quality Engineers
- Drive the transition from a paper-based system to electronic Document Control and Training modules within our QMS system
- Lead or facilitate regulatory audits and internal audits
- Oversee the supplier audit program
- Liaise with multiple CMOs
- Take charge of the Corrective and Preventive Action Process
- Ensure the Document Control system maintains compliance with regulations and procedures during changes to quality system documents
- Conduct training on quality assurance, internal procedures, and Good Manufacturing Practices
- Draft, execute, and/or authorize changes to controlled documents
- Uphold internal procedures for cGMP production in line with ISO 13485:2016 and FDA QSR
- Supervise QA staff, overseeing quality assurance duties
- Over 10 years of direct quality engineering and quality assurance experience in the medical device sector
- Experience working with contract manufacturers
- Experience implementing eQMS
- Experience in start-up or mid-sized companies is desirable
- Exposure to product transfers and integrations from product acquisitions is advantageous
- Working knowledge of ISO 13485:2016 and FDA QSR regulations
Senior Quality Assurance Manager - San Jose, United States - Connect Life Science
Description
Job Title: Senior Quality Assurance Manager
Compensation: $150,000 - $200,000, plus Comprehensive Benefits and Stock Options
Industry: Medical Devices
Location: San Jose, CA
We are seeking a seasoned leader in the field of Medical Devices, equipped with an engineering background and a proactive approach, to spearhead a team of 5 direct reports through the development phase of a new product, working closely with contract manufacturers and driving the implementation of a new eQMS system.
Responsibilities:
Experience:Bachelor's degree in a scientific or technical discipline