Quality Engineer II (Life Science/Med Device)

Job Title: Quality Engineer II

Location: Irvine, CA (Onsite)

Role Overview:
Seeking a Quality Engineer II with medical device industry experience to assess, remediate, and integrate an acquired company's Quality Management System (QMS). The role focuses on ISO 13485 compliance, gap assessments, corrective actions, and quality system improvement.

Must-Have Skills:

• 3–5 years of Quality Engineering experience in the medical device industry

• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820

• Experience conducting QMS gap assessments and implementing remediation plans

• CAPA, root cause analysis, and corrective action implementation

• Document control, nonconformance management, and risk management

• Authoring and revising quality procedures, work instructions, and controlled documents

• Internal audits, compliance assessments, and audit readiness

• Experience with electronic Quality Management Systems (eQMS)

• Cross-functional collaboration and project coordination

Preferred Qualifications:

• ISO 13485 Lead Auditor, ASQ CQE, or CQA certification

• Experience with MDSAP, FDA inspections, and certification audits

• Knowledge of ISO 14971, EU MDR, and medical device design controls

• Experience with QMS integration following mergers or acquisitions

• Experience with Class II or Class III medical devices

Education: Bachelor’s degree in Engineering, Biomedical Engineering, Quality, Life Sciences, or a related technical field.