Complaint Investigator

Philips; Bothell (WA); On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

PTO

401k matching

Health Savings Account

Stock purchase plan

Education reimbursement

Job summary

Philips in Bothell, WA is seeking a Complaint Investigator to lead end-to-end investigations of highly complex complaints, condense information, analyze findings, and present a clear overview with proposed resolutions.

The role requires a Bachelor's degree in a related field or equivalent experience, knowledge of post-market surveillance and CAPA, and ability to work onsite with regular collaboration across teams. You will help ensure regulatory compliance and contribute to product safety.

Qualifications

• 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.

Responsibilities

• Lead the end-to-end investigation of complaints, condense pertinent information, analyze findings, and present a concise overview of the inquiry process, including key issues identified, evidence gathered, and resolutions proposed or implemented.
• Review customer response letters (CRL) or internal responses upon concluding the investigation, utilize effective communication and problem-solving skills, and escalate complex matters to appropriate channels for further assistance and resolution.
• Utilize 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.
• Handle moderate to high complexity investigations into post-market complaints and adverse events, ensure thorough and timely resolution by analyzing complaint data and documentation to identify trends, root causes, and potential product issues.

Skills

Data analysis

Root cause analysis

CAPA

Regulatory knowledge

Education

Bachelor's degree or equivalent in Medical Sciences/Healthcare Management/Industrial Engineering/Supply Chain Management or related field

Job description

Job Title

Complaint Investigator

Job Description

In this role you

Are 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.

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.

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.

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 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.

Philips Transparency Details

The pay range for this position in Bothell, WA is $71,000 to $98,200 Annually.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell WA.

#LI-PHI

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.