QMS Remediation Specialist - CAPA & Compliance

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

Job summary

Philips in the United States is seeking a Quality System Specialist (QMS Remediation) to support remediation activities within a regulated medical device environment. You will review quality system records, support CAPA remediation, identify compliance gaps, and drive improvements to align with regulatory requirements and internal procedures.

The role collaborates with Quality, Regulatory Affairs, Engineering, Manufacturing, Clinical, and Operations teams.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, Regulatory Affairs, or a related discipline.
• Minimum 5 years of experience in Medical Device or regulated industry.
• Experience supporting Quality Management Systems and quality system processes.
• Working knowledge FDA QMSR / 21 CFR Part 820 and ISO 13485:2016.
• Proficiency with QMS and electronic document management systems.

Responsibilities

• Support QMS remediation plans and CAPA activities.
• Review quality system records to identify remediation actions.
• Remediate procedures, forms, work instructions for compliance.
• Support improvements across QMS processes.
• Collaborate with Quality, Regulatory, Engineering, Manufacturing, Clinical, and Operations teams.

Skills

CAPA Systems

Internal Audits

Regulatory Compliance

Technical Writing

Document Review

Quality Records

QMS software

Data Analysis

Education

Bachelor's degree in Engineering, Quality, Life Sciences, Regulatory Affairs, or related discipline

Job description

Philips in the United States is seeking a Quality System Specialist (QMS Remediation) to support remediation activities within a regulated medical device environment. You will review quality system records, support CAPA remediation, identify compliance gaps, and drive improvements to align with regulatory requirements and internal procedures.

The role collaborates with Quality, Regulatory Affairs, Engineering, Manufacturing, Clinical, and Operations teams.