Overview
Quality Assurance Technician Jobs in San Luis Obispo, CA at Empirical Systems Aerospace, Inc.
Job Title: Quality Engineer
Location: Warsaw IN
Duration: 2+ Years (Contract)
Job Summary:
Key Responsibilities:
Support DHF remediation activities for 6,500 SKUs across 36 product files.
Review and update Design History Files (DHF), Device Master Records (DMR), and risk management files to meet regulatory compliance.
Utilize Zimmer Biomet’s “The Vault” system to process documentation and ensure proper record-keeping.
Conduct gap assessments and implement remediation plans for missing or outdated quality documentation.
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR requirements.
Support risk management activities, including Failure Mode and Effects Analysis (FMEA) and hazard analysis.
Collaborate with design, regulatory, and manufacturing teams to ensure proper documentation and change control.
Assist in the preparation of regulatory submissions, audits, and inspections by providing updated documentation.
Lead or participate in Corrective and Preventive Actions (CAPA), Non-Conformances (NC), and Complaint Investigations.
Qualifications & Experience:
MUST HAVE: Experience working at Zimmer Biomet and using “The Vault” system.
3-7+ years of experience in medical device quality engineering.
Strong understanding of DHF remediation, risk management, CAPA, and quality systems.
Familiarity with FDA QSR, ISO 13485, EU MDR, and other global regulatory requirements.
Experience with design controls, verification/validation, and regulatory compliance audits.
Knowledge of process validation, change control, and documentation management.
Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Quality Engineering, or related field.
Strong analytical, problem-solving, and documentation skills.
Thank you,
Tarun Kumar Neyyala
Medical/Pharma Recruiter
Fusion Life Sciences Technologies LLC
Cell: 214-810-4936
Email ID: [email protected]
Job Type: Contract
Pay: $50.00 – $55.00 per hour
Schedule:
8 hour shift
Ability to Commute:
Warsaw, IN 46580 (Preferred)
Ability to Relocate:
Warsaw, IN 46580: Relocate before starting work (Preferred)
Work Location: In person
Show more
Title: Quality Assurance Technician
Company: Empirical Systems Aerospace, Inc.
Location: San Luis Obispo, CA
