Complaint Investigator

Philips • Bothell, WA

1d • $71,000 - $98,200

About The Position

The Complaint Investigator investigates and helps resolve highly complex complaints. The role leads comprehensive investigations, oversees complaint records, analyzes data for potential product enhancements, supports regulatory compliance, and helps train new investigators in complaint-handling processes and regulatory standards. Responsibilities include leading good faith efforts, reviewing supplementary data, conducting end-to-end investigations, summarizing findings and resolutions, reviewing customer or internal response letters, escalating complex matters, and investigating post-market complaints and adverse events to identify trends, root causes, and potential product issues.

Requirements

• Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or a related field; alternatively, 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, quality management systems (QMS), regulatory requirements, technical documentation, data analysis, root cause analysis, and CAPA methodologies.
• Must reside in or within commuting distance of Bothell, Washington.
• Must have US work authorization; sponsorship for a work-authorized visa is not available.

Nice To Haves

• Medical-device vigilance reporting experience.

Responsibilities

• Lead the implementation of good faith efforts (GFE), and review and analyze supplementary data to strengthen investigations.
• Lead end-to-end complaint investigations, condensing relevant information and presenting an overview of key issues, evidence, and proposed or implemented resolutions.
• Review customer response letters (CRL) or internal responses after investigations and escalate complex matters to appropriate channels.
• Resolve medium-complexity requests by analyzing complaint data and gathering information about potential product enhancements, defects, and safety issues.
• Conduct moderate- to high-complexity investigations into post-market complaints and adverse events, identifying trends, root causes, and potential product issues.
• Oversee complaint records, ensure thorough and timely investigation resolutions, and support regulatory compliance.
• Support training of new investigators in complaint-handling processes and regulatory standards.

Benefits

• Generous paid time off (PTO)
• 401(k) with up to 7% company match
• Health Savings Account (HSA) with company contribution
• Stock purchase plan
• Education reimbursement
• Annual incentive bonus, sales commission, or long-term incentives may be offered

What This Job Offers

• Job Type: Full-time