Post Market Surveillance Engineer

Philips•Bothell, WA

1d•$103,000 - $143,400•Hybrid

About The Position

In this role, you are responsible for overseeing complaint handling processes, facilitating communication between stakeholders, resolving complex complaints by liaising with business/market/clinical/product experts, mentoring and training new specialists, leading investigation teams, and ensuring accurate vigilance reporting to enhance product quality and customer satisfaction.

Requirements

Bachelor's/ Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
2+ years of experience in areas such as Complaint Handling Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent with Bachelor’s degree.
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.

Nice To Haves

3+ years of experience in medical device, Post Market Surveillance, Vigilance Reporting.

Responsibilities

Provides information on mid-complexity product-specific concerns, responds to moderate questions from complaint evaluators and complaint investigators, ensuring effective communication and support throughout the process.
Analyzes the quality of the complaint handling process, scrutinizes the performance of both the complaint evaluator and investigator, identifies bottlenecks and challenges encountered during the process and pinpoints areas for business process improvements to streamline operations and enhance customer satisfaction.
Works under limited supervision and broad guidelines and resolves complex complaints, evaluates initial assessments of reportability, promptly escalates to the manager for further determination and necessary action and ensures thorough analysis and resolution.
Facilitates the training and qualification process for new PMS complaint operations specialists, provides hands-on assistance, creates, and documents training materials, and offers ongoing mentorship and feedback to cultivate their skills and confidence.
Generates periodic reports on complaint trends and metrics, ensures accurate and timely documentation for internal review and regulatory submission, and maintains compliance with relevant standards.