CAPA Engineer

CAPA Engineer, Image Guided Therapy Devices

The CAPA Engineer is responsible for driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings for the Image Guided Therapy Devices business unit.

• Lead end-to-end CAPA investigations for product and process non-conformances, from issue identification through root cause analysis, implementation of corrective / preventive actions, and effectiveness monitoring. Ensure timely, accurate completion of CAPA records and supporting documentation.
• Project manage CAPA activities by coordinating cross‑functional teams, securing resource commitment, and driving adherence to timelines and deliverables. Facilitate CAPA meetings and ensure alignment across stakeholders to advance resolution.
• Apply structured problem‑solving and root cause analysis methodologies (e.g., PRIDE) while mentoring cross‑functional teams to strengthen investigation rigor and decision‑making. Support teams in developing robust, sustainable corrective and preventive actions.
• Analyze quality data trends using statistical techniques to identify systemic issues, emerging risks, and opportunities for prevention of non‑conformances. Translate data insights into actionable CAPA strategies.
• Serve as the CAPA subject‑matter representative during audits and review boards while partnering with management to ensure action plans are feasible, resourced, and aligned with business priorities.

• 5+ years of related experience with a bachelor’s degree or higher.
• Strong knowledge of relevant standards and regulations for the medical device industry (ISO, IEC, etc.) and experience owning, facilitating, or executing the CAPA process within a medical device company.
• Bachelor’s or higher in Engineering, Science, or an equivalent combination of education and related experience.
• You must be able to successfully perform the following minimum Physical, Cognitive, and Environmental job requirements with or without accommodation for this position.
• Excellent communicator, able to influence cross‑functional stakeholders utilizing CAPA expertise.

We believe that we are better together than apart. For our office‑based teams, this means working in‑person at least 3 days per week. On‑site roles require full‑time 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.

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.

The pay range for this position in Colorado Springs, CO is $92,000 to $146,000.

The pay range for this position in San Diego, CA is $103,000 to $163,000.

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.

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, 401(k) (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement, and much more. Details about our benefits can be found here.

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.

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 posted locations.

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