Senior Quality Engineer

Philips; Bedford (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Philips is seeking a Senior CAPA & Investigation Specialist to support a high-priority QMS remediation initiative. This role focuses on reviewing, assessing, and remediating existing CAPA records to ensure documentation meets regulatory requirements and inspection readiness.

The ideal candidate has medical device industry experience, strong CAPA leadership, investigations skills, and a track record of remediation after audits or regulatory observations.

Qualifications

• Bachelor's degree required.
• Medical Device industry experience required.
• Demonstrated CAPA ownership and leadership experience.
• Experience conducting quality investigations.
• Strong Root Cause Analysis experience.
• Working knowledge of ISO 13485 requirements.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820/QMSR).
• Strong technical writing and documentation skills.
• Experience supporting quality system remediation projects.
• Ability to independently review and assess large volumes of quality records and documentation.

Responsibilities

• Review historical CAPA records and supporting documentation.
• Assess investigations for completeness, effectiveness, and regulatory compliance.
• Identify and remediate documentation deficiencies and compliance gaps.
• Conduct and support root cause analysis activities.
• Evaluate corrective and preventive actions for adequacy and effectiveness.
• Review and validate effectiveness checks.
• Strengthen investigation quality and documentation integrity.
• Support quality system remediation initiatives and inspection readiness efforts.
• Partner with cross-functional stakeholders to drive CAPA remediation activities to closure.

Skills

CAPA Management

Technical Writing

Quality System Remediation

Regulatory Compliance

Inspection Readiness

Documentation Review and Remediation

Cross-Functional Collaboration

Education

Bachelor's degree

Tools

Greenlight Guru

Job description

Philips is seeking a Senior CAPA & Investigation Specialist to support a high-priority Quality Management System (QMS) Remediation initiative. This individual will be responsible for reviewing, assessing, and remediating existing CAPA records to ensure documentation meets regulatory requirements and supports inspection readiness.

The ideal candidate will have extensive experience within the medical device industry, a strong background in CAPA management and investigations, and demonstrated success supporting remediation activities following audits, inspections, or regulatory observations.

Responsibilities

• Review historical CAPA records and supporting documentation.
• Assess investigations for completeness, effectiveness, and regulatory compliance.
• Identify and remediate documentation deficiencies and compliance gaps.
• Conduct and support root cause analysis activities.
• Evaluate corrective and preventive actions for adequacy and effectiveness.
• Review and validate effectiveness checks.
• Strengthen investigation quality and documentation integrity.
• Support quality system remediation initiatives and inspection readiness efforts.
• Partner with cross-functional stakeholders to drive CAPA remediation activities to closure.

Required Qualifications

• Bachelor's degree required.
• Medical Device industry experience required.
• Demonstrated CAPA ownership and leadership experience.
• Experience conducting quality investigations.
• Strong Root Cause Analysis experience.
• Working knowledge of ISO 13485 requirements.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820/QMSR).
• Strong technical writing and documentation skills.
• Experience supporting quality system remediation projects.
• Ability to independently review and assess large volumes of quality records and documentation.

Preferred Qualifications

• Experience supporting FDA 483 remediation activities.
• Experience remediating CAPA records following audits, inspections, or regulatory observations.
• Experience with Greenlight Guru or similar electronic Quality Management Systems.
• Experience supporting inspection readiness programs.
• Advanced knowledge of CAPA and quality system requirements within the medical device industry.

Preferred Skills

• CAPA Management
• Technical Writing
• Quality System Remediation
• Regulatory Compliance
• Inspection Readiness
• Documentation Review and Remediation
• Cross-Functional Collaboration

Preferred Methodologies

• 5 Whys
• Fishbone (Ishikawa)
• Fault Tree Analysis

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.