Sr. Quality Manager - Global Post Market Surveillance and Complaint Handling

Sr.

Quality Manager - Global Post Market Surveillance and Complaint Handling

Job Description

 

You’re not the person who will settle for just any role.

Neither are we.

Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference.

Here, you’ll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands.

In this role, you’ll help us deliver better care for billions of people around the world.

It starts with YOU.  

The Post Market Quality Senior Manager will oversee operational activities related to the global post market product complaint handling process.  The Senior Manager will lead the team of post-market quality professionals providing day to day oversight and direction to individuals who receive, assess, investigate, and facilitate timely and accurate regulatory reporting activities as applicable.

They will follow established global regulations for complaint handling and prepare and assemble complaint information for regulatory inquiries and management review.

This person will provide support during inspections by regulatory bodies as directed by Management.  This person will work with functional partners such as Research & Engineering, Supply Chain, Product Safety, Consumer Engagement, Medical Affairs and Regulatory for global Post Market Surveillance activities.

In this role, you will: 


* Oversee Complaint processing in compliance with applicable regulations and standards such as FDA Quality System Regulation, 21 CFR Part 820, 803, ISO 13485:2016.


* Manage personnel and all associated activities of the Post-Market Surveillance Team including managing performance and developing talent.


* Manage the timely in-flow of customer complaints, the assignment of investigation responsibilities, and expedient processing and closure.


* Maintains a key role in continually examining current complaint handling processes to ensure day to day operations meet regulatory and business requirements. 


* Responsible for oversight of Adverse Event reporting program to ensure compliance.


* Work closely with manufacturing sites and engineering to ensure thorough and accurate investigations and drive the initiation of CAPAs when appropriate.


* Define reports, monitor, and prevent delinquency or backlog in all aspects of the surveillance process.


* Identify process improvement opportunities to enhance surveillance and to increase efficiency.


* Develop and maintain Complaint processing.


* Manage preparation and reporting of quality data for purposes of post market surveillance and as the primary input into the Management Review process.


* Based on surveillance findings, collaborate with technical groups to identify product improvement opportunities; assist in establishing engineering priorities.


* Review Health Risk/Hazard Assessments as n...