Product Quality Manager - Product Projects
Oticon - Bring sound to millions of people worldwide
Oticon is one of the largest companies in the hearing healthcare industry worldwide. The company is part of the William Demant Group with more than 13.000 employees, 1,300 in Denmark, and various companies within hearing healthcare.
Make a true difference! By joining the Oticon team, you help bring sounds to the millions of hearing impaired all over the world, so they can live natural lives with friends and family.
The headquarter just outside Copenhagen has been created to foster daily cross-disciplinary collaboration. The open environment is made for interaction between people and it encourages dialogue and mutual inspiration. Oticon offers a wide range of clubs, training facilities and one of the finest canteens in Denmark.
An open-minded environment
At Oticon, you will meet an organization of enthusiastic and open-minded people. It demands technical knowledge and professional competencies to develop, produce and market the best hearing aids in the world. However, it also takes dedicated people who have the freedom to innovate and who understands to develop their knowledge together with others. Therefore, you will meet room for innovation and skilled, enthusiastic employees who wants to make a difference.
It is crucial for the business to have only the best employees and specialists. Therefore, a continuous focus is on the development of all people in the organization. It is your individual talent and expertise that defines the tasks you can handle at Oticon, with more focus on your personality than on your formal educational background.
Product Quality Manager - Product Projects
- Worldwide leading company within hearing solutions
- Important role and influence within medical device R&D Projects
- Project Lead who drives development within quality and compliance
You can be part of this success by joining the Project Management Team, which consists of 10 highly dedicated colleagues and is part of the Quality Assurance & Regulatory Affairs department.
The group drives development activities with focus on quality and compliance of the product. It runs various types of development projects – e.g. hw or sw platform projects and device or sw product projects. Many PQM activities are identical for all project types, but some are specific for project types.
The team is running the projects and activities in an environment where classification, risk management file processes, device and facility registrations, radio approvals, electrical safety approvals plus standard and regulation requirements are part of the daily business.
Furthermore, the team is involved in internal audit and system compliance according to EN ISO 13485 and FDA 21 CFR 820. The team is also continuously involved in improvement projects.
You are willing to make a difference and together with ambitious and talented colleagues, you will be part of a dynamic department.
You will participate in different projects as Project Lead for quality & regulatory compliance. As a company with very high expectations to quality and regulatory compliance, you are committed to excel in an environment with these important focus areas.
Your tasks as PQM among others are:
- Driving quality targets and quality requirements definition and reviews
- Driving compliance to e.g. FDA 21 CFR part 820, ISO 14971, IEC 62304, IEC 60601, IEC 62366
- Driving team of Q-Specialists in a Matrix organization
- Driving milestone quality status reviews
- Driving quality/compliance rationales and declarations
- Driving product type and country approvals
- Driving audit support and follow up
- Driving plans for monitoring product quality on the market
Oticon offers an exciting position within a dedicated company, which is characterized by trust and openness. You will support the business in order to ensure, that the products are the most attractive on the market. You will be given the opportunity to put your mark on the job and many opportunities for personal and professional development. Since Oticon experience growth, there will be good career opportunities within the organization. You will be referring to the Director of Product Quality Management.
You have a relevant education like B.Sc/M.Sc in Engineering or a similar relevant background combined with minimum 4 years of experience with focus on product development or quality. You have knowledge within Software, Mechanics, Electronics, Material Science and Production Technology from the field Medical Device.
You are used to be working with Project Management and Regulatory Approvals where you are responsible for the progress within the projects.
You are a strong communicator, self-motivated, positive and committed. You think business oriented and have the ability to organize and plan your tasks. It is important that you are focused, can prioritize and keep calm when deadlines are tight. You are good at solving problems and thrive in a busy environment.
You are fluent in English, both written and spoken. In other words, you have a desire to support and enrich Oticon´ s culture. You appreciate to work in a worldwide leading company, where knowledge sharing, and mutual professional respect makes it fun and meaningful to work.
Best Talent is responsible for your employment at Oticon and review your application on a confidential basis. Forward your application including your CV in Danish or English marked ”1636/ PQM” by e-mail to firstname.lastname@example.org or Best Talent, Strandvejen 724, Klampenborg. You can read more about Best Talent on www.besttalent.dk.