QMS & CAPA Lead for Regulatory Excellence

Philips; Bothell (WA); Presencial; USD 102 000 - 164 000; Tempo integral

Resumo da oferta

Philips in Bothell, WA is seeking an experienced Quality Management System (QMS)/CAPA Specialist to lead CAPA processes and support Audit Readiness within the Personal Health QMS team.

You will monitor process performance, prepare detailed reports, present findings to senior management, and drive continuous improvement. The role requires at least 3 years in CAPA/QMS in regulated environments and a Bachelor’s degree in Quality or Engineering. Onsite work 3+ days per week is expected.

Qualificações

• Minimum 3+ years in CAPA management, QMS, and quality audits in regulated industries (Medical Device, Pharma, or Automotive).
• Knowledge of global medical device regulations (QMSR, ISO 13485, ISO 9001; EU MDR preferred).
• Experience with CAPA cycle: problem identification, root cause analysis, corrective actions, effectiveness verification.
• Strong data analysis and KPI reporting to leadership.
• Bachelor’s Degree in Quality, Engineering or related; ASQ-CQE is a plus.
• Ability to work onsite 3+ days/week; full-time presence.

Responsabilidades

• Own CAPA processes in assigned areas and ensure regulatory compliance.
• Analyze QMS metrics, prepare reports, and present to senior management.
• Lead cross-functional problem-solving sessions (root cause analysis).
• Develop, implement and revise SOPs and quality manuals.
• Prepare for external audits and respond to findings with stakeholders.

Conhecimentos

CAPA management

QMS

Audits

Data analysis

Root cause analysis

Regulatory compliance

Formação académica

Bachelor’s Degree

Descrição da oferta de emprego

Philips in Bothell, WA is seeking an experienced Quality Management System (QMS)/CAPA Specialist to lead CAPA processes and support Audit Readiness within the Personal Health QMS team.

You will monitor process performance, prepare detailed reports, present findings to senior management, and drive continuous improvement. The role requires at least 3 years in CAPA/QMS in regulated environments and a Bachelor’s degree in Quality or Engineering. Onsite work 3+ days per week is expected.