QMS & CAPA Excellence Lead for Medical Devices

Philips; Bothell (WA); On-site; USD 102,000 - 164,000; Full time

Benefits offered by this job

PTO

401k

HSA

Stock plan

Education reimbursement

Job summary

Philips in Bothell, WA is seeking a Quality Management System/CAPA Specialist to drive CAPA processes, audit readiness, and document control within the Personal Health QMS. You will monitor QMS performance, prepare detailed reports, and present findings to senior management to guide continuous improvement.

Leverage your CAPA experience to lead cross-functional problem solving, develop SOPs, and ensure regulatory compliance in a fast-paced environment.

Qualifications

• Minimum 3+ years’ experience in CAPA management and QMS in regulated environments (Medical Device/Pharma/Automotive).
• Knowledge of global medical device regulations and standards (QMSR, ISO 13485, ISO 9001; EU MDR preferred).
• Experience with CAPA process: problem ID, root cause analysis, corrective action, effectiveness verification.
• Experience training and supporting CAPA teams.
• Strong data analysis and detailed QMS metrics reporting to management.

Responsibilities

• Facilitate CAPA process and audit readiness activities to ensure a compliant QMS.
• Monitor process performance, prepare detailed reports, and present findings to senior management.
• Develop and revise SOPs, work instructions, and quality manuals for accuracy and compliance.
• Lead cross-functional problem-solving and risk mitigation initiatives within QMS.
• Participate in external regulatory audits and respond to audit findings with stakeholders.

Skills

CAPA management

Quality Management Systems

Data analysis

Root cause analysis

Report writing

Cross-functional collaboration

Education

Bachelor’s Degree in Quality, Engineering, or similar

Tools

Document Control

Job description

Philips in Bothell, WA is seeking a Quality Management System/CAPA Specialist to drive CAPA processes, audit readiness, and document control within the Personal Health QMS. You will monitor QMS performance, prepare detailed reports, and present findings to senior management to guide continuous improvement.

Leverage your CAPA experience to lead cross-functional problem solving, develop SOPs, and ensure regulatory compliance in a fast-paced environment.