Do you want to be a member of a team that ensures that Oticon complies with the ISO 13485:2016, MDSAP and FDA CFR 21 part 820?
We are looking for a candidate in our quality audit team, with 5 years’ experience in quality, preferable QA in medical devices. A relevant master’s degree in engineering or natural science will also be of good use. Audits will be an important part of the job and you therefore need to have knowledge and experience in ISO 13485, MDSAP, EU MDD/MDR, and FDA 21CRF part 820.
Joining Our team
You will be part of the Quality Assurance team, with 10 dedicated employees. Our team are placed partly in Smørum and partly in Stettin in Poland. The vacant position is located in Smørum. The role of our team is to support our global organization with QA knowledge. We conduct internal audits and host external audits/ inspections and are responsible for setting the quality direction for our company. We are responsible for the quality management system and are driving strategic improvement and compliance projects across our organization.
The impact you can make
As a part of the QA team, you will support both Quality and the organization with your knowledge on QA subjects. This includes:
- Be an internal auditor
- Participate in external audits preferable as a quality guide or at the back office
- And be involved in ongoing improvement of our processes in QA
The job requires a great deal of cooperation with other internal departments in our global organization.
Your profile and personal skills
We are looking for a person who thrives in a complex organization with multiple stakeholders and different organizational structures. You have a pragmatic way to demonstrate your broad knowledge of QA requirements and tools. You like to be part of an engaged team and see your success as the team’s success. We empower each other and show confidence in you because you possess a high personal integrity and ample people skills, making you a valued team-player in the organization.
Above all, we value your ability to work with a collaborative approach and build trust with others. You are a strong and engaging communicator – verbally and in writing – and you work closely with people at all levels of the organization. You have a strong business acumen and can work across the business in multiple countries.
You will be traveling approximately 15 days per year.
We dare to make a difference
Together with your ambitious and talented colleagues, you will be part of a dynamic environment built on trust and openness, where you will find a strong will to win. We are a growing international company, where everyone strives to ensure that customers find our products the most attractive on the market. You will become part of a work environment where flexible working conditions, knowledge-sharing and professional respect make it both challenging and meaningful to go to work.
Want to join the team?
Kindly submit your application as soon as possible but no later than August 16, 2022, as we’re going to interview candidates on an ongoing basis. We only accept applications via our online recruitment system. If you would like to know more about the position, you are welcome to contact Mette Rittmeyer Senior Quality Audit Manager on MRIT@Demant.com or Lone Eskildsen, Senior Director Quality Assurance on LOEK@demant.com (because of vacation, expect longer processing).
We are looking forward to hearing from you.
500 million people worldwide suffer from hearing loss. It is Oticon's ambition that our customers - hearing clinics throughout the world - prefer to use our products for people with impaired hearing. Oticon is one of the two largest companies in the industry, and in Denmark all 1,600 employees, with passion, dedication and professional expertise, develop some of the most innovative hearing aids in the world. Oticon is an international growing company, and 98% of Group revenues is generated outside Denmark. We are part of the Demant Group with more than 16,500 employees and revenues of more than 16 billion.