Sr Quality Engineer – Medical Device

Sr Quality Engineer – Medical Device

Location: Santa Ana, California (Fully onsite)

Type: W2 contract

Duration: 12 months

Must‑Have

• Experience with Nonconformance material reports, CAPAs, and FMEA.
• 4+ years of experience in Quality Engineering or a related field in the medical device or regulated industry.
• Work in a team environment and cross‑collaboration with multiple functional groups.

Education Required

Bachelor’s degree in Engineering, Science, or a related technical field.

Position Overview

As a Quality Engineer, you will play a key role in ensuring that products and processes comply with regulatory requirements. You’ll collaborate cross‑functionally to drive continuous improvement, support manufacturing, and ensure the highest levels of product quality and patient safety. The role includes hands‑on support in controlled environments, involvement with animal‑origin tissue, and active participation in daily production activities.

Key Responsibilities

• Provide quality engineering support for manufacturing, sustaining, and new product introduction.
• Participate in daily manufacturing tier meetings to support production and address quality‑related concerns.
• Be present in controlled environment areas/clean rooms to monitor processes, support investigations, and ensure compliance with quality standards.
• Work with tissue from animal origin (porcine and bovine) in accordance with safety and regulatory requirements.
• Investigate product non‑conformances and implement corrective and preventive actions (CAPA).
• Lead or participate in process validation activities (IQ/OQ/PQ).
• Ensure compliance with FDA QSR, ISO 13485, and other applicable regulations.
• Review and approve process and product changes.
• Analyze data, conduct risk assessments, and support root cause analysis.
• Lead or support internal and external audits.
• Participate in the development and review of quality documentation (procedures, protocols, reports).

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field.
• 4+ years of experience in Quality Engineering or a related field in the medical device or regulated industry.
• Experience with Nonconformance material reports, CAPAs, and FMEA.
• Able to work with Bovine and Porcine tissue.
• Working knowledge of FDA regulations and ISO 13485.

Preferred Qualifications

• Experience with CAPA, risk management (FMEA), and process validation.
• ASQ certification (CQE, CQA) is a plus.
• Strong communication and teamwork skills.
• Experience with statistical analysis and data interpretation.