Senior Quality Specialist: Complaint Remediation Expert

Philips; Bedford (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Philips is seeking a Quality System Remediation Specialist to review medical device complaint records, assess compliance with FDA regulations and ISO 13485, and strengthen documentation. You will collaborate with Quality, Regulatory Affairs, Engineering, Clinical, Service, and Manufacturing teams to close gaps and ensure inspection readiness.

With a Bachelor's in Engineering or related field and 5+ years in device complaint handling, you will drive remediation activities, perform risk

Qualifications

• Bachelor's degree in Engineering, Quality, Regulatory Affairs, or related field.
• 5+ years of medical device complaint handling experience.
• Experience reviewing complaint files and leading remediation activities.
• Knowledge of MDR, root cause investigations, and risk management.
• Strong technical writing and analytical skills.
• Ability to manage a high volume of complaint records with accuracy.
• Comfortable working cross-functionally in a regulated environment.

Responsibilities

• Conduct retrospective reviews of complaint records as part of remediation.
• Assess complaint files for compliance with FDA regulations and ISO 13485.
• Identify documentation gaps, deficiencies, and remediation needs.
• Review investigations to ensure complete and compliant documentation.
• Perform reportability assessments, risk evaluations, and trend analyses.
• Remediate complaint records and update documentation.
• Partner with Quality, Regulatory Affairs, Engineering, Clinical, Service, and Manufacturing to obtain evidence.
• Support remediation activities tied to CAPAs, audits, and inspections.
• Generate objective evidence showing remediation completion.
• Ensure complaint records are audit-ready and inspection-ready.
• Contribute to continuous improvement of complaint handling processes.

Skills

Complaint handling

MDR knowledge

Root cause analysis

Technical writing

Analytical skills

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Quality/Regulatory Affairs

Tools

eQMS (Greenlight Guru)

Job description

Philips is seeking a Quality System Remediation Specialist to review medical device complaint records, assess compliance with FDA regulations and ISO 13485, and strengthen documentation. You will collaborate with Quality, Regulatory Affairs, Engineering, Clinical, Service, and Manufacturing teams to close gaps and ensure inspection readiness.

With a Bachelor's in Engineering or related field and 5+ years in device complaint handling, you will drive remediation activities, perform risk