Coloplast has an exciting opportunity for a Post Market Quality Assurance Manager to join our growing team!

This position is essential to the compliance of the company with FDA and international regulatory authorities. This position is responsible for leading, maintaining and developing the post market team, including continuous improvement of the complaint handling and post market surveillance program for Interventional Urology Implantable Devices (IU ID).

Major Areas of Accountability

• Lead and continuously improve the overall complaint handling program
• Manage complaint investigations and analysis of complaint data, including returned product analysis
• Define appropriate standards, methods, and workflows for the complaint management systems
• Communicate with internal customers to analyze and document product complaint information and ensure timely investigation of, and response to, product complaints
• Manage direct reports, ensuring duties, responsibilities, authority, and expectations for direct reports are defined and understood
• Improve team performance with cohesiveness by leading, influencing, training, and motivating to facilitate cooperation, ensure efficiency, boost morale and drive success
• Provide guidance to staff and respond to escalated and/or complex product complaint investigations and corrective actions
• Responsible for development and implementation of methods and procedures for effective trending
• Create, deploy, and monitor appropriate metrics and drive action to respond to signals
• Responsible for developing content and lead facilitation of monthly product review meetings
• Provide appropriate data driven solutions to reduce cost of quality and improve monitoring system efficiency
• Manage appropriate escalations and communication of high priority and/or complex complaints and corrective actions
• Partner with Regulatory on reporting complaints to external regulatory agencies
• Support internal and external audits; including facilitation of external audits, as needed
• Additional duties as assigned

Basic Qualifications

• Bachelor's degree from a four-year college or university in a relevant science or engineering discipline
• Minimum of 3-5 years related experience and/or relevant training
• Experience managing a team of direct reports
• 3-5 years in a medical device development or manufacturing environment required
• Strong statistical background
• Experience with Class II and Class III implantable medical devices is desired
• Able to travel, both domestic and international, as required

Required Knowledge, Skills and Abilities

• Excellent verbal and written English communication skills
• Ability to directly manage and develop a team
• Excellent analytical and problem-solving skills
• Internal quality auditor experience (ASQ certification desired)
• Ability to methodically analyze data and identify trends
• Experience with FDA regulations (21 CFR Part 820), ISO standards (13485, 14971), & EU MDR

Environmental, Health and Safety Responsibilities

This position will support Coloplast Manufacturing EHS Goals and Objectives:

• Enforce all company Environment, Health, and Safety policies
• Ensure employees are properly trained
• Provide detailed instructions for job performance and explain hazards and safety precautions in assigning employees to a task
• Plan the work to be certain that employees, material, and equipment are available to perform task safely.
• Promptly report all incidents in area(s) of responsibility
• Conduct effective accident investigations immediately after they occur and implement effective corrective actions to ensure that the accident does not reoccur
• Ensure injured employees receive proper first aid and/or medical treatment
• Follow-up on all safety related deficiencies to ensure corrective action has been completed
• Actively support and promote Environment, Health, and Safety activities within the organization