Quality Management System/CAPA Specialist

Philips • Bothell, WA

4d • $102,480 - $163,968 • Onsite

About The Position

For the Personal Health QMS Audit and CAPA team, the Quality Management System (QMS)/CAPA Specialist facilitates the CAPA process and supports audit readiness activities to maintain an efficient, compliant QMS. The role owns processes in assigned areas, including CAPA, audit readiness, and related document control and training. It monitors process performance, analyzes QMS metrics, prepares detailed reports, presents findings to senior management, and participates in continuous improvement activities.

Working under broad guidelines and limited supervision, the specialist applies independent judgment to significant matters and contributes to the development, implementation, and revision of QMS processes and documentation. The role conducts risk assessments, helps mitigate risks to compliance and quality, leads cross-functional problem-solving, and supports external regulatory audits and inspections. It also cultivates relationships with internal and external partners and keeps current with quality standards, regulations, and QMS procedures.

This is an office-based role. Office-based teams work in person at least three days per week. The position requires residence in or within commuting distance of Bothell, Washington; relocation benefits are not provided. US work authorization is required, and sponsorship is unavailable. The posted base-pay range is $102,480 to $163,968. Additional compensation may be offered, and employees may participate in Philips Total Rewards benefits.

Requirements

• At least 3 years of experience in CAPA management, Quality Management Systems, or Quality Audits in a highly regulated industry such as medical devices, pharmaceuticals, or automotive.
• Bachelor’s degree in Quality, Engineering, or a similar discipline.
• Detailed CAPA process knowledge or experience, including problem identification, root cause analysis, corrective action planning, effectiveness verification, technical writing, and CAPA timeliness management.
• Experience analyzing data and reporting QMS metrics and KPIs, identifying trends, deviations, and improvement opportunities, and presenting findings to senior management.
• Ability to build and cultivate relationships with supervisors, functional peer groups, and internal and external stakeholders.
• Ability to successfully perform the position’s minimum physical, cognitive, and environmental job requirements, with or without accommodation.
• US work authorization; candidates requiring visa sponsorship now or in the future will not be considered.
• Must reside in or within commuting distance of Bothell, WA.

Nice To Haves

• FDA-regulated medical device experience preferred.
• Knowledge of global medical device regulations, requirements, and standards such as QMSR, ISO 13485, ISO 9001, and EU MDR preferred.
• ASQ-CQE certification desired.

Responsibilities

• Own assigned processes in CAPA, audit readiness, and related document control and training to ensure the QMS is efficient and meets regulatory requirements.
• Analyze QMS metrics and performance indicators, prepare detailed reports on trends, deviations, and improvement opportunities, 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.
• Lead cross-functional problem-solving sessions on significant QMS issues, using methods such as root cause analysis and driving implementation of solutions.
• Prepare for and participate in external regulatory audits and inspections by ensuring documentation, processes, and records are ready; collaborate on responses to audit findings.
• Participate in training and learning opportunities to stay current on quality standards, regulations, and QMS procedures.
• Build effective relationships with internal and external partners and influence projects and peer groups.

Benefits

• Generous paid time off (PTO).
• 401(k) with up to 7% company match.
• Health Savings Account (HSA) with company contribution.
• Stock purchase plan.
• Education reimbursement.
• Comprehensive Philips Total Rewards benefits program.
• Additional compensation, such as an annual incentive bonus, sales commission, or long-term incentives, may be offered.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level