Quality Systems Leader: QMS & Compliance Expert

Philips International; Bedford, Northern (MA, KY); Hybrid; USD 102,000 - 164,000; Full time

Benefits offered by this job

PTO and Paid Time Off

401(k) plan with match

Health Savings Account (HSA)

Education reimbursement

Job summary

Philips in Bedford, MA seeks a Senior Quality Systems Engineer to own and improve the QMS, including audits, document control, training and CAPA. You will analyze QMS metrics, develop SOPs, and lead cross-functional teams to drive compliant, efficient quality processes.

With 5+ years in FDA/ISO 13485 medical device quality, you will mentor engineers, support external audits, and collaborate across stakeholders. This office-based role requires in-person presence three days per week.

Qualifications

• Minimum 5+ years’ experience in FDA/ISO 13485 medical device quality operations/manufacturing environments.
• Experience with CAPA, audits, document control, training and QMS changes.
• ASQ-CQE or ISO Lead Auditor certifications are desirable.

Responsibilities

• Owns quality processes including audits, document control, training and CAPA to ensure QMS compliance.
• Analyzes QMS metrics and prepares reports for senior management.
• Develops and revises SOPs, work instructions, and quality manuals.
• Leads cross-functional problem-solving and root cause analysis to implement lasting solutions.
• Prepares for external regulatory audits and responses to findings.

Skills

Quality management

Audits

CAPA

Document control

Training

KPI analysis

Cross-functional leadership

Root cause analysis

Mentoring

Education

Bachelor’s Degree in Quality, Engineering or similar

ASQ-CQE

ISO Lead Auditor certification

Job description

Philips in Bedford, MA seeks a Senior Quality Systems Engineer to own and improve the QMS, including audits, document control, training and CAPA. You will analyze QMS metrics, develop SOPs, and lead cross-functional teams to drive compliant, efficient quality processes.

With 5+ years in FDA/ISO 13485 medical device quality, you will mentor engineers, support external audits, and collaborate across stakeholders. This office-based role requires in-person presence three days per week.