Senior Quality Specialist

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

In this role, you have the opportunity to support a critical Quality System Remediation initiative by reviewing, assessing, and strengthening medical device complaint records to ensure compliance with applicable regulatory requirements and internal quality standards. You will work closely with cross-functional stakeholders to identify documentation gaps, enhance complaint investigations, and help ensure complaint files are inspection ready.

Your role:

• Conduct retrospective reviews of complaint records as part of quality system remediation activities.
• Assess complaint files for compliance with applicable FDA regulations, ISO 13485 requirements, and global regulatory standards.
• Identify documentation gaps, deficiencies, and missing objective evidence requiring remediation.
• Review complaint investigations to ensure appropriate problem descriptions, investigations, root cause assessments, conclusions, and supporting documentation are complete and compliant.
• Perform reportability assessments, risk evaluations, and trend analyses as required.
• Remediate complaint records through the completion of required quality system activities and documentation updates.
• Partner with Quality, Regulatory Affairs, Engineering, Clinical, Service, and Manufacturing teams to obtain supporting evidence and resolve documentation gaps.
• Support remediation activities associated with CAPAs, audits, inspection observations, and quality system improvement initiatives.
• Generate objective evidence demonstrating completion of remediation activities.
• Ensure complaint records are audit-ready and inspection-ready.
• Contribute to continuous improvement efforts that strengthen complaint handling processes and overall quality system effectiveness.

You're the right fit if:

• You have a Bachelor's degree in Engineering, Quality, Regulatory Affairs, or a related discipline.
• You have 5+ years of medical device complaint handling experience.
• You have experience conducting complaint file reviews, complaint remediation activities, or quality system remediation initiatives.
• You possess strong knowledge of complaint handling processes, Medical Device Reporting (MDR), root cause investigation methodologies, and risk management principles.
• You have strong technical writing, documentation, and analytical skills.
• You can independently manage a high volume of complaint records while maintaining accuracy, consistency, and attention to detail.
• You are comfortable working cross-functionally in a fast-paced, highly regulated environment.

Preferred Qualifications

• Experience supporting FDA inspection readiness or regulatory remediation efforts.
• Experience supporting CAPA remediation initiatives.
• Experience working within electronic Quality Management Systems (eQMS), including Greenlight Guru.
• Experience supporting medical device quality system compliance programs.

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.