Philips
Technical Complaint Investigation Specialist
At Philips, we are at the forefront of creating innovative health technology solutions that redefine user experiences worldwide. Our commitment to improving lives drives us to seek out the brightest minds to join our dynamic teams. As a multinational leader in healthcare, we pride ourselves on fostering a collaborative environment where technical excellence, creativity, and ownership are highly valued.
The Role:
We are looking for a passionate and skilled Technical Complaint Investigation Specialist to join our team. In this role, you will be responsible for leading technical investigations of high-risk complaints, ensuring robust root cause analyses, and driving product and process improvements. Your work will be vital to maintaining our high standards for patient safety, regulatory compliance, and customer satisfaction.
Key Responsibilities:
Perform and coordinate technical investigations of high-risk complaints, including preparation of strategies and detailed reviews.
Act as a liaison between R&D, Clinical, Manufacturing, Sustaining Engineering, and other teams to drive thorough complaint investigations.
Create and deploy technical investigation guidelines for malfunctions and new reportable corrections and removals (C&Rs).
Identify patterns in complaints and support CAPA intake and product defect analysis.
Review failed parts reports and support the failed parts return process.
Drive improvements through the use of AI/LLM tools to enhance complaint investigations.
Represent the business in regulatory inquiries and audits related to complaint handling.
Support Quality Management System (QMS) activities including vigilance reporting, CAPAs, corrections, and removals.
Analyze complaint data, gather additional data as needed, and support feedback loops for product and process improvements.
Support training initiatives, creating and delivering training materials on complaint handling processes.
Requirements:
Bachelor’s or Master’s degree, preferably in Engineering or Science.
7+ years of related experience in a medical device or regulated industry, ideally within R&D (software/hardware) and/or Quality functions.
Strong understanding of complaint handling, adverse event reporting, and post-market surveillance.
Familiarity with regulatory standards such as 21 CFR Parts 803, 806, 820, ISO 13485, ISO 14971, European MDD, Canadian MDR, and Japanese MHLW Ordinance 169 is considered a plus.
Experience within Philips Healthcare medical devices is a plus.
Soft Skills:
Strong analytical and problem-solving abilities.
Excellent written and verbal communication skills.
Proactive and quality-focused mindset.
High engagement, flexibility, and the ability to work across multidisciplinary teams.
What We Offer in Return:
Impactful Work: Directly contribute to patient safety and product excellence.
Development Team: Collaborate with highly skilled professionals in Quality and R&D.
Inspiring Work Environment: Access to state-of-the-art tools and a global knowledge network.
Career Growth: Opportunities for professional development in a global health technology leader.
Innovation Culture: Work in an environment that encourages continuous improvement and creative problem-solving.
Additional Information:
Hybrid Work: Minimum 3 days per week onsite in Eindhoven.
Contract Type: You will work for Philips as a contract or permanent employee of a Randstad company, with access to a range of benefits and development opportunities.
Business Impact: Your role will be crucial in strengthening product quality, ensuring regulatory compliance, and ultimately improving healthcare outcomes for millions worldwide.
About Philips:
Philips is a health technology company built on the belief that every human matters. We strive to ensure everyone has access to quality healthcare and innovative solutions. As part of our team, you will contribute to life-changing projects that improve lives around the world.