Complaint Investigator
Philips
Summary
Responsible for meticulously investigating and assisting in resolving highly complex complaints, leading comprehensive investigations, overseeing complaint records, analyzing data for potential product enhancements, ensuring regulatory compliance, and supporting the training of new investigators in complaint handling processes and regulatory standards.
Job description
Your role
- Leads the implementation of good faith efforts (GFE), diligently reviews, and analyzes supplementary data as required to fortify the investigation process and demonstrates a commitment to thoroughness and accuracy.
- Leads the end-to-end investigation of complaints, including condensing pertinent information, analyzing findings, and presenting a concise overview of the inquiry process, including key issues identified, evidence gathered, and resolutions proposed or implemented.
- Reviews customer response letters (CRL) or internal responses upon concluding the investigation, utilizes effective communication and problem-solving skills, and escalates complex matters to appropriate channels for further assistance and resolution.
- Utilizes analytical skills to resolve medium complexity requests by exercising judgment within established procedures, analyzing complaint data, gathering additional information to assess potential product enhancements, defects, and safety issues.
- Handles moderate to high complexity investigations into post-market complaints and adverse events, ensures thorough and timely resolution by analyzing complaint data and documentation to identify trends, root causes, and potential product issues.
You're the right fit if
- Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or a related field; or vocational education with at least 4 years of relevant experience.
- Experience in medical devices, quality assurance or control, clinical research, complaint management, or a related area.
- Knowledge of post-market surveillance, QMS and regulatory requirements, technical documentation, data analysis, root cause analysis, and CAPA methodologies. Medical-device vigilance reporting experience is a plus.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
Requirements
- Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or a related field; or vocational education with at least 4 years of relevant experience
- Experience in medical devices, quality assurance or control, clinical research, complaint management, or a related area
- Knowledge of post-market surveillance, QMS and regulatory requirements, technical documentation, data analysis, root cause analysis, and CAPA methodologies
- Medical-device vigilance reporting experience is a plus
- US work authorization required; no visa sponsorship
Benefits
- Paid Time Off
- 401(k) Matching
- Health Savings Account
- Stock Purchase Plan
- Education Reimbursement
Company overview
Koninklijke Philips N.V., commonly known as Philips, is a Dutch multinational health technology company that has evolved from its origins as a consumer electronics conglomerate into a leading global healthcare solutions provider. Founded in 1891 in Eindhoven, Netherlands, Philips has transformed its business focus since the 2010s to concentrate exclusively on health technology. The company operates through three main divisions: Diagnosis and Treatment, which manufactures advanced medical imaging equipment including MRI, CT, and ultrasound scanners; Connected Care, specializing in patient monitoring systems and respiratory care products under the Respironics brand; and Personal Health, producing consumer healthcare products like electric shavers, Sonicare toothbrushes, and Avent childcare items. With 68,419 employees worldwide and annual revenues of €18.02 billion (2024), Philips maintains its global headquarters in Amsterdam while operating manufacturing, R&D, and sales facilities across 26 countries. The company has strategically divested its consumer electronics, lighting, and home appliance businesses to become a pure-play health technology organization, positioning itself at the forefront of medical innovation and digital healthcare solutions.