Quality System Specialist

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

Quality System Specialist (QMS Remediation)

Philips is seeking a Quality System Specialist (QMS Remediation) to support critical Quality Management System remediation activities within a regulated medical device environment. This role will focus on reviewing quality system records, supporting CAPA remediation efforts, identifying compliance gaps, and driving quality system improvements to ensure alignment with regulatory requirements and internal procedures.

Responsibilities

• Support the execution of QMS remediation plans and associated CAPA activities.
• Conduct retrospective reviews of quality system records to identify compliance gaps and required remediation actions.
• Review and remediate procedures, forms, work instructions, and quality records for compliance with regulatory and procedural requirements.
• Support quality system improvements across multiple QMS processes.
• Assist remediation efforts related:
• CAPA
• Document Control
• Training
• Management Review
• Internal Audits
• Nonconforming Product
• Design Controls
• Generate and maintain objective evidence supporting remediation completion.
• Support effectiveness checks and verification activities associated with remediation CAPAs.
• Assist with gap assessments against FDA QMSR, ISO 13485, and internal procedures.
• Maintain remediation trackers, metrics, and status reports for leadership review.
• Support audit and inspection readiness activities.
• Collaborate cross-functionally with Quality, Regulatory Affairs, Engineering, Manufacturing, Clinical, and Operations teams.

Required Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Regulatory Affairs, or a related discipline.
• Minimum 5 years of experience within Medical Device, Diagnostics, Pharmaceutical, or another regulated industry.
• Experience supporting Quality Management Systems and quality system processes.
• Working knowledge of:
• FDA QMSR / 21 CFR Part 820
• ISO 13485:2016
• CAPA Systems
• Internal Audits
• Training Systems
• Quality System Documentation
• Quality Records Management
• Strong technical writing and document review skills.
• Experience reviewing large volumes of records and identifying compliance gaps.
• Proficiency with Quality Management Systems (QMS) and electronic document management systems.

Preferred Skills

• Regulatory Compliance
• Quality Management Systems (QMS)
• Project Management
• Process Improvement
• Technical Writing
• Data Analysis and KPI Reporting
• Root Cause Analysis and Troubleshooting
• Training Development and Delivery
• User Training and Support
• Agile Methodology
• Business Acumen

What you’ll gain:

When you choose to work at Philips you’ll work on life-changing projects; and contribute to innovative health technologies and solutions that improve lives around the world. It could be life-changing for you too, with the opportunity to embrace new experiences, learn new skills and make new connections.

For this project, you’ll work for Philips and become a contract or permanent employee of a Randstad company. As a contractor at Philips, you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional. And as an employee of a Randstad company, you can expect to receive a range of benefits including ongoing support with your personal development and future prospects.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. As a contractor or freelancer at Philips, you’ll be part of our diverse collaborative team, helping the lives of others through the contribution you make each day.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by a Randstad company and will not be an employee of Philips.