Senior QMS Engineer - Regulatory & Quality Leader

Mass Digital Health; Massachusetts; On-site; USD 102,000 - 164,000; Full time

Benefits offered by this job

PTO and benefits

401k match

HSA with company contribution

Stock purchase plan

Education reimbursement

Total Rewards program

Job summary

Philips in Bedford, MA is seeking a Senior Quality Systems Engineer to own the QMS, audits, document control and CAPA processes, ensuring compliance with FDA/ISO13485 standards. The role analyzes QMS metrics, prepares detailed reports for senior management, and drives continuous improvement across processes, SOPs, and quality manuals with cross-functional teams.

You will lead training initiatives, manage risk assessments, and collaborate with suppliers and internal stakeholders to maintain

Qualifications

• 5+ years’ experience in FDA/ISO 13485 medical device quality operations/manufacturing environments.
• Experience managing/maintaining training metrics/matrix.
• Proven experience leading cross‑functional teams and mentoring engineers.
• Detailed CAPA experience including root cause analysis and corrective actions.
• Experience in data analysis and presenting KPI reports to management.
• Ability to build relationships with supervisors and stakeholders.
• Bachelor’s Degree (Required) in Quality, Engineering or similar; ASQ-CQE and ISO Lead Auditor certifications desirable.
• Must meet minimum physical, cognitive and environmental job requirements.

Responsibilities

• Own quality processes including audits, document control, training, CAPA to ensure QMS efficiency and regulatory compliance.
• Analyze QMS metrics and prepare reports for senior management, highlighting trends and deviations.
• Develop, implement and revise QMS processes, SOPs, work instructions, and quality manuals.
• Conduct risk assessments and develop mitigation strategies to minimize regulatory and quality risks.
• Participate in continuous improvement initiatives within the QMS.
• Apply specialized knowledge to drive innovative solutions across projects.
• Participate in training to stay updated on quality standards and QMS procedures.
• Cultivate relationships with internal and external partners and stakeholders.
• Lead cross-functional problem-solving sessions using root-cause analysis and implement solutions.
• Prepare for and participate in external regulatory audits; respond to audit findings.

Skills

Quality Management Systems

Audit leadership

CAPA management

Data analysis

Cross-functional leadership

Training metrics

Root cause analysis

Education

Bachelor’s Degree in Quality/Engineering

Job description

Philips in Bedford, MA is seeking a Senior Quality Systems Engineer to own the QMS, audits, document control and CAPA processes, ensuring compliance with FDA/ISO13485 standards. The role analyzes QMS metrics, prepares detailed reports for senior management, and drives continuous improvement across processes, SOPs, and quality manuals with cross-functional teams.

You will lead training initiatives, manage risk assessments, and collaborate with suppliers and internal stakeholders to maintain