Post Market Surveillance Manager

Philips • Reedsville, PA

4d • $120,000 - $186,000 • Hybrid

About The Position

In this role you Are responsible for overseeing post-market surveillance processes, enhancing reporting systems, managing team talent, designing training programs, conducting quality assurance assessments, leading process improvement efforts, applying statistical methods, implementing best practices, and investigating moderate product complaints to ensure regulatory compliance and drive continuous improvement.

Requirements

• Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
• 5+ years of experience with Bachelor's in areas such as Post Market Surveillance Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent.
• 5+ years of experience in leading teams with direct and indirect reports in complex matrix organizations and delivering on organizational objectives.
• Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

Responsibilities

• Oversees the implementation of post market surveillance processes, ensures adherence to predefined parameters and standards, and ensures operations are conducted within established guidelines, contributing to efficiency and consistency in outcomes.
• Reviews reporting systems to track and analyze execution progress and enhances reporting tools and procedures to ensure timely and accurate reporting, enabling effective oversight of ongoing tasks and initiatives.
• Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
• Designs comprehensive training programs on regulatory compliance, adverse event reporting, product complaint handling, risk management, recall management, quality management systems, documentation, and continuous improvement initiatives.
• Oversees meticulous quality assurance assessments on developed communication tools and ensures their accuracy in reporting and effectiveness in generating response plans to maintain regulatory compliance and address post-market surveillance concerns.
• Develops team management action plans, reviews progress, ensures timely completion and designs systematic tracking mechanisms to evaluate effectiveness, facilitating continuous improvement initiatives within the organization.
• Oversees medium to large scale process improvement efforts, coordinates analysis, design, and implementation phases to enhance operational efficiency and align with organizational objectives.

Benefits

• generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• stock purchase plan
• education reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Manager