Quality Operations Specialist

Pentangle Tech Services | P5 Group; Irvine (CA); On-site; USD 70,000 - 110,000; Full time

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.

Job description

Review and investigate assigned technical and clinical customer complaints. Perform

technical investigations and document results per established procedures and timelines.

Supports quality functions pertaining to manufacturing line support and maintenance,

including SAP.

Performs hands‑on troubleshooting of customer returned devices and manufacturing

nonconformities and completes associated technical documentation

Assist complaint intake group through review and verification of initial complaint coding.

Monitor post‑market and manufacturing product performance through evaluation and

trending of customer complaints, service calls, and manufacturing rejections. Ensure that

appropriate corrective actions are implemented to address the root cause of trending

issues.

Support and coordinate product/process improvements through collaboration with cross[1]functional teams (Quality, Manufacturing, R&D, Supply Chain, Finance, etc).

Ensure compliance with the company's Quality System policies and procedures and

applicable external requirements and standards, including FDA, ISO 13485, and other

worldwide regulatory agencies pertaining to medical devices

Experience: 2-5 years

Familiarity with regulatory reporting requirements for medical devices (e.g., MDRs,

Familiarity with medical device complaint files and quality records.

Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard.

Demonstrated written and verbal communication skills

Bachelor’s degree in electrical engineering or mechanical engineering HIGHLY

PREFERRED. Other Engineering degrees or Natural Science degrees to be considered with

RELEVANT experience in MEDICAL DEVICE TROUBLESHOOTING.