Head of Post Market Quality Quality · Multiple locations

To deliver on our corporate purpose of making a wonderful sound part of everyone’s life, WS Audiology is looking for a new Head of Post Market Quality to manage the company’s processes for Complaint Handling, Complaints Investigations, Vigilance, and Field Actions.

This position is available in several countries, including Singapore, Poland (Poznań), Denmark (Lynge), and the US.

Your Team
In this role, you will be an integral part of our Quality organization, leading a global team of 30-40 employees, including four direct reports. You will collaborate closely with both internal stakeholders and external vendors to drive continuous improvement in our complaint management processes, ensuring efficiency and quality across the board.

What you will do
This is an exciting opportunity to lead the implementation of a new complaints management system, a key initiative under the direction of the new Head of Post Market Quality. We are looking for a dynamic individual to oversee this transformation, manage the global Quality team, and integrate Quality standards into all aspects of operations while ensuring strict compliance with Quality requirements.

Your new role will be to:

• Ensure processes and procedures for complaint handling, vigilance, and Field Actions are established,
• Ensure compliance with applicable regulations such as FDAs 21 CfR Part 803, 806, and 8L0, European legislations,
• Ensure compliance with MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System and any additional requirements for authority adverse event reporting if applicable,
• Ensure initiation, coordination, and completion of Field Actions /Recalls according to applicable regulations,
• Provide input to Post Market Surveillance meetings in complaints history, trend reviews, Adverse incidents / Medical Device reporting, and Recalls/ Field Safety Corrective Actions,
• Trend analysis and reporting on product performance, complaints, vigilance, and field actions,
• Report to the Notified Body and applicable authorities on Vigilance and Field Actions,
• Work with applicable Regulatory Agencies by providing answers and clarifications to potential Agency questions.

What you bring
To succeed in this role, you must bring strong leadership experience coupled with expertise in Quality and medical device complaints management. We are seeking a forward-thinking leader who excels at driving the implementation of innovative solutions while effectively collaborating with and managing a global team.

Experience

• 5+ years of experience in Quality, preferably within the med-tech industry,
• University degree in Engineering or a related field,
• In-depth knowledge of global quality standards and regulations, including FDA 21 CFR Part 803, 806, and 820, as well as relevant European legislation,
• Strong expertise in MEDDEV 2.12-1 Guidelines,
• Proven experience in managing the end-to-end complaints process, including complaint trending and handling complaints with negative outcomes,
• Experience in implementing best practices and driving the adoption of new solutions is highly desirable.

Personal competencies

• Strong people management skills, and ability to manage global team, as well as to make impactful decisions,
• Excellent verbal and written communication skills, enabling effective collaboration in cross-functional global teams,
• A proactive and creative approach to problem-solving, complemented by innovative thinking.

Our corporate language is English, so you need to be fluent in English, both verbally and in writing.

Who we are

At WS Audiology, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.

WS Audiology is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.

Department
Quality

Locations
Lynge, Copenhagen Region, Denmark, Poznań , Singapore

Employment type
Full-time

Contact Dagmara Leszczynska TA Associate EMEA LA CA – Human Resources

Colleagues

Mike Lim

Global Talent Acquisition Manager