Medical Device Quality Operations Investigator

Pentangle Tech Services | P5 Group

Irvine (CA)

On-site

USD 70,000 - 110,000

Full time

14 days+

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Job summary

Pentangle Tech Services | P5 Group is seeking a detail‑oriented engineer to investigate medical device complaints and perform technical investigations. You will document results per procedures and timelines, support quality functions including SAP, and troubleshoot returned devices and nonconformities.

You will monitor post‑market performance, trend service data, and drive corrective actions with cross‑functional teams.

Qualifications

2–5 years of experience in medical devices or related field.
Familiarity with FDA regulations (21 CFR Part 820 and Part 803) and ISO 13485.
Strong written and verbal communication skills.
Bachelor’s degree in electrical or mechanical engineering.

Responsibilities

Review and investigate assigned technical and clinical customer complaints.
Perform technical investigations and document results per procedures and timelines.
Support quality functions for manufacturing line support and maintenance, including SAP.
Troubleshoot customer returned devices and manufacturing nonconformities; document results.
Assist complaint intake by reviewing and verifying initial complaint coding.
Monitor post‑market and manufacturing product performance; trend complaints and service data.
Implement corrective actions addressing root causes of trending issues.
Collaborate cross‑functional teams (Quality, Manufacturing, R&D, Supply Chain, Finance) on product/process improvements.
Ensure compliance with Quality System policies, FDA, ISO 13485 and other related regulations.