Quality Management System/CAPA Specialist

Philips•Bothell, WA

3d•Onsite

About The Position

The Quality Management System/CAPA Specialist supports the Personal Health QMS Audit and CAPA team by facilitating the CAPA process and supporting audit readiness activities to maintain an efficient, compliant Quality Management System. The role owns assigned processes in CAPA, Audit Readiness, and related Document Control and Training; monitors QMS performance; analyzes metrics; prepares reports; and presents findings to senior management. The specialist works under limited supervision and applies independent judgment to significant matters. The role contributes to developing, implementing, and revising QMS processes, SOPs, work instructions, and quality manuals. It conducts risk assessments and develops mitigation strategies, participates in continuous improvement, and applies specialized knowledge to complex projects. The specialist leads cross-functional problem-solving using root cause analysis, builds relationships with internal and external partners, and supports CAPA teams through training. The role also prepares for and participates in external regulatory audits and inspections, ensuring documentation, processes, and records are ready and collaborating with stakeholders on audit finding responses. This is an office-based position for candidates residing in or within commuting distance of Bothell, Washington. Office-based teams work in person at least three days per week. The posted base pay range is $102,480 to $163,968. Philips offers a comprehensive benefits program, and relocation benefits are not provided.

Requirements

At least 3 years of experience in CAPA management, Quality Management Systems, or Quality Audits in a highly regulated industry such as medical device, pharmaceutical, or automotive.
Bachelor's degree in Quality, Engineering, or a similar discipline.
Detailed experience or knowledge of the CAPA process, including problem identification, root cause analysis, corrective action planning, effectiveness verification, technical writing, and CAPA timeliness management.
Experience in data analysis and detailed reporting of QMS metrics and KPIs, including identifying trends, deviations, and improvement areas and presenting findings to senior management.
Ability to build and cultivate relationships with supervisors, functional peer groups, and internal and external stakeholders.
Knowledge of global medical device regulations, requirements, and standards.

Nice To Haves

Experience in FDA-regulated medical devices.
Knowledge of QMSR, ISO 13485, ISO 9001, and EU MDR.
ASQ-CQE certification.

Responsibilities

Own assigned CAPA, Audit Readiness, Document Control, and Training processes to ensure the QMS is efficient and meets regulatory requirements.
Analyze QMS metrics and performance indicators, prepare detailed reports on trends, deviations, and improvement areas, and present findings to senior management.
Contribute to developing, implementing, and revising QMS processes, SOPs, work instructions, and quality manuals.
Conduct risk assessments and develop mitigation strategies for risks to regulatory compliance, quality, and QMS integrity.
Participate in continuous improvement initiatives and propose and implement enhancements to processes, tools, and systems.
Participate in training to stay current on quality standards, QMS procedures, industry regulations, and best practices.
Cultivate relationships with internal and external partners and influence projects and peer groups.
Lead cross-functional problem-solving sessions on significant QMS issues, using structured methods such as root cause analysis and driving solution implementation.
Prepare for and participate in external regulatory audits and inspections by ensuring documentation, processes, and records are ready.
Collaborate with stakeholders to respond to audit findings.
Train and support CAPA teams.