Quality Reviewer; Medical Device​/Pharma​/Regulated Industry

Quality Reviewer (Medical Device/Pharma/Regulated Industry)

Location Requirements: Hybrid in Princeton NJ (Tues/Wed/Thurs on site)

Duration: 6+ months

Quality Reviewer – Medial Devices

Required Skills

• 2+ years experience with complaints in medical device, pharma background, FDA regulated industry experience
• Closing out complaint records
• Strong attention to detail
• Ability to read investigation records, question root causes and discrepancies, conduct failure analysis
• Volume about 100-150 per week once up to speed
• Experience with CAPAs is not required
• Experience in FDA regulated industry (preferred)

Key Responsibilities

• Review and assess the accuracy, completeness, and compliance of all complaint records (including parent and child records) in accordance with internal procedures and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, MDR).
• Provide clear, actionable quality feedback to complaint owners and investigators to ensure high-quality documentation and adherence to quality system standards.
• Verify that all complaint files undergo Internal Quality Review and are completed, approved, and closed within defined timelines.
• Confirm that investigation records accurately document the root cause analysis, corrective actions, and justification for closure.
• Facilitate stakeholder meetings when necessary to clarify complaint details, investigation expectations, or closure requirements.
• Ensure complaint files are audit‑ready and capable of standing alone during internal, external, or regulatory audits.
• Identify trends, process gaps, and recurring issues, and collaborate with cross‑functional teams to drive continuous improvement in complaint handling and closure processes.

Skills and Competencies

• Strong analytical skills with attention to detail and accuracy in documentation review.
• Excellent written and verbal communication skills for effective collaboration with global and cross‑functional teams.
• Demonstrated ability to coach, mentor, and train team members to improve complaint quality and compliance.
• Proven ability to organize, prioritize, and manage multiple complaint records to meet closure timelines.
• Experience in identifying and implementing continuous improvement initiatives within a regulated quality system environment.

Impellam Group and its brands are equal‑opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre‑employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting H or fill out this form to request accommodations.