QA Analyst, Salesforce
The Walt Disney Company
CloudSelenium
Senior Quality Engineer
Avive Solutions Inc.
full-time
Posted on:
Location Type: Hybrid
Location: Brisbane • California • 🇺🇸 United States
Visit company websiteSalary
💰 $140,000 - $160,000 per year
Job Level
Senior
About the role
- Provide quality engineering support for manufacturing operations (in-house and contract manufacturing)
- Establish and maintain robust in-process and final inspection criteria; support production ramp-up and continuous improvement
- Support process validation activities (IQ/OQ/PQ) and ensure compliance with ISO 13485 and FDA 21 CFR Part 820
- Develop and maintain the supplier quality program, including supplier selection, audits, qualification, and performance monitoring
- Manage supplier non-conformances and corrective actions to ensure timely and effective resolution
- Ensure compliance with design control requirements; author, review, and approve DHF, risk management files, and V&V protocols and reports
- Support design transfer activities to manufacturing and collaborate cross-functionally on change control
- Lead root cause investigations, implement CAPAs, and support internal and external audits and regulatory submissions
Requirements
- 5+ years of quality or manufacturing engineering experience in medical devices
- BS in Engineering (preferably Electrical, Mechanical or Biomedical)
- Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and applicable IEC/ISO standards (e.g., IEC 60601)
- Strong interpersonal, and communication skills
- ASQ CQE, or related certification a plus.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality engineeringprocess validationsupplier quality programroot cause investigationCAPAdesign controlrisk managementV&V protocolsauditscontinuous improvement
Soft skills
interpersonal skillscommunication skills
Certifications
ASQ CQE
