Staff Engineer, Quality Assurance
Job Title: Staff Engineer, Quality Assurance
Reports To: Senior Director, Quality Assurance
Implement, support, and sustain elements of the Miramar Labs Quality System to maintain compliance with applicable regulatory requirements including the FDA Quality System Regulation (21 CFR Part 820), California FDB, EN ISO 13485, and EN ISO 14971.
- Provide primary quality engineering support to manufacturing and service activities. Support product development as needed.
- Make decisions related to product quality and release
- Generate and approve test protocols and reports, including design verification and validation, packaging and sterilization validation
- Oversee equipment management system, including specifications, qualifications, calibration, and maintenance
- Manage nonconforming material controls and represent Quality Assurance on Material Review Board
- Perform internal and supplier quality audits
- Support software change controls and problem reporting
- Assess current practices against external standards, regulations, and guidance documents
- Prepare and present quality trend analyses for reporting through quality system processes, including Management Reviews, CAPA, and Risk Management
- Participate in device hazard and risk analyses
- Actively work to promote team building and morale within the department and company
Education and/or Experience:
- Bachelor of Science in technical or scientific discipline
- Minimum 10 years related experience in the medical device industry
- Prior lead auditor experience or lead auditor training (e.g., ASQ certified auditor or RAB lead auditor certification)
- Demonstrated knowledge of EN ISO 13485,EN ISO 14971, and FDA QSR requirements
- Demonstrated ability to apply risk management techniques
- Strong written and oral communication skills
If you would like to apply for this position, please email your resume to email@example.com.