Quality Complaint & Product Return Manager

Quality Complaint & Product Return Manager for Oticon Medical BAHS, Gothenburg
Do you want to improve the life of people with a hearing disability? Are you an Engineer with passion for quality and technology? Then we might have an exciting position for you as Quality Complaint & Product Return Manager at Oticon Medical BAHS in Gothenburg.
At Oticon Medical BAHS we develop and market bone anchored hearing systems including implants, sound processors, software and various accessories. We are now looking to add a great new member to our joint QARA, Operations and Product care organization were we among other key tasks, are responsible for regulatory compliance, quality management system, complaint handling, production and change management of all in-market products.
You will be responsible for all aspects of complaint handling, vigilance reporting and product returns, and report directly to the Senior Director, QARA & Operations.
Complaint handling and vigilance reporting are key processes in the company ensuring that we have safe and reliable products on the market. That we react to upcoming problems in a fast and structured way. And that we support our customers and users with an efficient service process ensuring they always have access to sound. In addition, we secure that we are following global regulatory requirements on vigilance reporting.
Your responsibilities
You have the overall responsibility for the complaint, vigilance and return processes, where you drive process improvements and represent the areas in audits as process owner and subject matter expert.
Furthermore, your tasks will be:
Define and be accountable for all procedures and instructions for own areas
Ensure efficient reporting of complaints from the market through training and support to worldwide distributors
Conduct technical investigations of all product related complaints (Bone anchored implants, sound processors and accessories)
Support and train technicians in our Polish production site in technical investigations of product returns for service
Drive complaint root cause investigations with different stakeholder and suggest corrective and preventive actions
Establish documentation related to all complaints
Prepare vigilance reports to different markets according to regulatory requirements
Efficient communication to worldwide distributors related to complaints
Prepare trending reports, analyze statistics, drive required actions and ensure input to product development
Conduct Quality Surveillance programs
Host complaint meetings with global distributors and internal stakeholders
Maintain the complaint system
Define and ensure implementation of an efficient product return system


Your experience and qualifications
You come along with a degree in Engineering and a minimum of 5 years of work experience within the field of Quality, R&D, production, or product support in the medical devices industry. You have an analytical, thorough, and structured approach to problem solving and take full responsibility of your business area. As we are a networking community, you should like to share your knowledge and ideas with the team and across the organization and have excellent skills in communicating with many stakeholders.
We expect that you have technical and analytical skills to investigate and determine failure of the products investigation, and understand the regulatory requirements related to complaint handling and vigilance reporting for high class medical devices.
We dare to make a difference
Together with skilled colleagues, you are part of a dynamic environment based on trust and openness, and you will experience a strong will to win. We are a growing international company where everybody supports the business by contributing to the customers’ experience of our products as the most attractive to work with. You will be working in a bright and open workplace, where a flexible working environment, knowledge sharing, and professional respect makes it both challenging and meaningful to go to work.
Would you like to know more?
Then send your application and CV through our online recruitment system as soon as possible and no later than 1st of December 2020. Please do not send us your application via e-mail.
If you would like to know more about the position, you are welcome to contact Senior Director Karolin Isberg Jernby on KIJE@oticonmedical.com.
We are looking forward to hearing from you.
Because sound matters
Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the magical world of sound to people at every stage of life. As part of the Demant group, a global leader in hearing healthcare with 15,000 people in over 130 countries, we have access to one of the world’s strongest research and development teams, the latest technological advances and insights into hearing care.
Our competencies span more than a century of innovations in sound processing and decades of pioneering experience in hearing implant technology. We work collaboratively with patients, physicians and hearing care professionals to ensure that every solution we create is designed with users’ needs in mind. We share an unwavering commitment to provide innovative solutions and support that enhance quality of life for people wherever life may take them.
Because we know how much sound matters.