8 Jobs
Connect Life Science is Hiring a Senior Quality Assurance Manager Near San Jose, CA
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:
- 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
Experience: Bachelor's degree in a scientific or technical discipline
- 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
Job Summary
Full Time
$125k-154k (estimate)
06/14/2024
07/02/2024
The following is the career advancement route for Senior Quality Assurance Manager positions, which can be used as a reference in future career path planning. As a Senior Quality Assurance Manager, it can be promoted into senior positions as a Quality Assurance Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Quality Assurance Manager. You can explore the career advancement for a Senior Quality Assurance Manager below and select your interested title to get hiring information.
