Job Title

Sr Quality Compliance Specialist

Job Description

Your role:

• Lead and support CAPA investigations end-to-end, including issue identification, root cause analysis (5 Whys, Ishikawa, statistical analysis), corrective actions, effectiveness checks, and closure in line with regulatory and QMS requirements.
• Partner cross-functionally with Quality, Engineering, Manufacturing, Service and Commercial teams to ensure timely execution of CAPA actions, adequate resourcing, and sustained compliance.
• Monitor and analyze quality data to identify risks, trends, and emerging non-conformances, enabling proactive compliance interventions and continuous improvement.
• Strengthen the compliance culture by training and mentoring teams on QMS, CAPA, regulatory expectations, and best practices across the organization.

You're the right fit if:

• Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
• Minimum of 3 years of experience in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive OR no prior experience required with Master's Degree.
• At least 2 years experience in Root cause analysis.
•  Strong Understanding of CAPA process, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485 EUMDR,  and ISO9001. 
•  Advanced English Level.
• Availability to commute to Philips Costa Rica site in Coyol free zone (3 days a week).

How we work together
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.
Onsite 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.

This is an office 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 the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.