Quality Management System/CAPA Specialist

Job Title

Job Description

For the Personal Health QMS Audit and CAPA team we're looking for an experienced Quality Management System (QMS)/CAPA Specialist, who will be responsible for facilitation of the CAPA process and supporting Audit Readiness activities to ensure an efficient/compliant Quality Management System (QMS). This includes monitoring process performance, preparing detailed reports, presenting findings to senior management and active participation in continuous improvement activities.

Your role:

• Takes ownership of processes in the assigned area/ areas (CAPA, Audit Readiness and related Document Control, Training) to ensure that QMS is efficient and meets the regulatory requirements.
• Analyzes QMS metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.
• Works under limited supervision and broad guidelines, regularly applying independent judgment on matters of significance to drive project success and compliance.
• Contributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.
• Conducts risk assessments activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and developing robust mitigation strategies to minimize their impact.
• Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.
• Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team, ensuring effective solutions and innovative approaches to complex challenges.
• Participates in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.
• Cultivates effective relationships with internal and external partners, providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization.
• Leads cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
• Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.

You're the right fit if:

• You have a minimum of 3+ years’ experience in CAPA management, Quality Management Systems, Quality Audits in highly regulated environments/industries such as Medical Device, Pharma or Automotive. FDA regulated Medical Device preferred.
• You have proven knowledge of global medical device regulations, requirements, and standards, such as QMSR, ISO 13485, ISO 9001, and EU MDR-preferred.
• You have detailed experience/knowledge of the CAPA process, including problem identification, root cause analysis, corrective action planning, effectiveness verification, technical writing and CAPA timeliness management. You train and support CAPA teams accordingly.
• You’re experienced in Data analysis, detailed reporting of QMS metrics/KPI’s, highlighting trends, deviations, areas for improvement, and presenting findings to senior management.
• You’re able to build/cultivate relationships with supervisors, functional peer groups, and internal/external stakeholders.
• You have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines. ASQ-CQE certification-desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office-based role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

• The pay range for this position in Bothell, WA is $102,480 to $163,968.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

Additional Information:

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.