Senior Quality Compliance Specialist

Job Title

Senior Quality Compliance Specialist

Job Description

The Senior Quality Compliance Specialist supports the Corrective and Preventive Action (CAPA) process from issue identification to closure, ensuring adequate execution of processes and quality of CAPA record content by assessing complex investigations, corrective actions, reviewing test/performance data, leading complex root cause analysis and quality problem solving.

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.
• Strengthening 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:

• You have a minimum of 5+ years of experience in FDA regulated manufacturing/quality environments, with a focus on CAPA investigations, Process improvement, Quality Management Systems, Audit support, and root cause analysis.
• You have a strong Understanding of the end-to-end 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. 
• You're able to analyze quality data to identify risks, trends, and emerging non-conformances
• You have a minimum of a Bachelor's Degree in Engineering, Sciences, similar disciplines or equivalent.
• You have advanced level communication in English (verbal/written).
• 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 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 of 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.

Additional Information:

• For this position, candidates must be able to commute to Philips Alajuela, Costa Rica site in Coyol Free Zone at least 3 days a week.