Quality Reviewer - Medial Devices

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

Duration: 6+ months

Required Skills

• 2+ years experience with complaints in med device, pharma background, FDA regulated industry experience
• Closing out complaint records
• Must have demonstrated strong attention to detail
• Must be able to read investigation records and question root causes and discrepancies, conduct failure analysis
• Volume is about 100-150/ week once they are up to speed
• Other titles - investigation, engineer, experience with CAPAs is NTH

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.

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

Duration: 6+ months

Required Skills

• Looking for someone with some experience with complaints
• Need help closing out complaint records
• Must have demonstrated strong attention to detail
• Must be able to read investigation records and question root causes and discrepancies, conduct failure analysis
• Attachments in complaint record match the notes in the file
• Will serve as the final set of eyes on the complaint record
• Volume is about 100-150/ week once they are up to speed
• Can come from an FDA regulated industry
• Other titles - investigation, engineer, experience with CAPAs is NTH

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 HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.