Senior Quality Systems Engineer

About the role

The Senior Quality Systems Engineer will lead the development, maintenance and continuous improvement of Philips’ Quality Management System (QMS) for medical device manufacturing. You will ensure compliance with FDA, ISO 13485 and other regulatory requirements while driving performance monitoring and risk mitigation.

Key responsibilities

• Own QMS processes such as audits, document control, training, and CAPA to guarantee regulatory compliance.
• Analyze QMS metrics, prepare detailed reports on trends and deviations, and present findings to senior management.
• Develop, revise and maintain SOPs, work instructions and quality manuals.
• Conduct risk assessments and implement mitigation strategies.
• Lead cross‑functional problem‑solving sessions using root‑cause analysis and drive implementation of corrective actions.
• Prepare for and support external regulatory audits and inspections.

Required profile

• Minimum 5 + years experience in FDA/ISO 13485 medical‑device quality operations.
• Proven ability to lead cross‑functional teams and mentor junior engineers.
• Experience managing training metrics and matrices.
• Bachelor’s degree in Quality, Engineering or related field; ASQ‑CQE or ISO Lead Auditor certification preferred.

Required skills

• FDA and ISO 13485 regulatory knowledge.
• Quality Management System (QMS) implementation and audit expertise.
• CAPA management and root‑cause analysis.
• Risk assessment and mitigation.
• Data analysis, KPI tracking and reporting.

What we offer

• Base salary range $102,480 – $163,968 per year.
• Comprehensive total‑rewards package including PTO, 401(k) match, HSA, stock purchase plan and education reimbursement.
• Office‑based role with at‑least‑three‑days‑per‑week on‑site work in Bedford, MA.