Senior Quality Systems Engineer - QMS & Compliance Lead

Philips; Bedford (MA); On-site; USD 102,000 - 164,000; Full time

Job summary

Philips in Bedford, MA is seeking a Senior Quality Systems Engineer to safeguard the effectiveness of our QMS. You will own audits, document control, CAPA, and training programs, driving compliance with FDA/ISO 13485 requirements across the organization.

You’ll analyze QMS metrics, develop robust SOPs and quality manuals, perform risk assessments, and lead cross-functional teams to implement improvements while preparing for regulatory audits and inspections.

Qualifications

• Minimum 5+ years in FDA/ISO 13485 medical device quality operations/manufacturing.
• Experience managing training metrics/matrix.
• Proven leadership of cross-functional teams and mentoring engineers.
• Experience with CAPA processes, root cause analysis and corrective actions.

Responsibilities

• Own audits, document control, training, and CAPA within the QMS.
• Analyze QMS metrics and report trends to leadership.
• Develop and revise SOPs, work instructions, and quality manuals.
• Perform risk assessments and implement mitigations.
• Lead cross-functional problem-solving and CAPA actions.
• Prepare for regulatory audits and respond to findings.

Skills

QMS compliance

Audits

Document Control

CAPA

Data analysis

Training metrics

Education

Bachelor's Degree in Quality, Engineering or related field

ASQ-CQE (desirable)

ISO Lead Auditor certification (desirable)

Tools

Audit tracking systems

QMS software (e.g., TrackWise)

Job description

Philips in Bedford, MA is seeking a Senior Quality Systems Engineer to safeguard the effectiveness of our QMS. You will own audits, document control, CAPA, and training programs, driving compliance with FDA/ISO 13485 requirements across the organization.

You’ll analyze QMS metrics, develop robust SOPs and quality manuals, perform risk assessments, and lead cross-functional teams to implement improvements while preparing for regulatory audits and inspections.