Quality Assurance Manager
Would you like to work with products that actually change the lives of people worldwide and do it in a fast-growing company? Then you may be a good match for Oticon Medical. Right now, we are looking for a dedicated and highly skilled QA manager to support our fast-growing business.
At Oticon Medical BAHS we develop and market bone anchored hearing systems including permanent implants, sound processors, software and various accessories. We are now looking to add a great new member to our QA/RA team consisting of seven dedicated and highly skilled colleagues. The team is responsible for the quality management system, CAPA, complaints and all regulatory aspects related to our products. The position is situated in our Gothenburg office and you will be reporting to the Senior Director QA/RA & Operations.
In your new job, you will be supporting the organisation in quality compliance – driving QMS projects, establish new processes and maintaining the quality management system. This includes but is not limited to;
- Preparing, implementing and supervising the compliance of quality procedures
- Driving definition and implementation of new efficient QMS processes to support the growing organisation
- Identification and utilization of QMS synergies between entities in the Demant group for smooth integration between collaboration partners
- Implementation and validation of QMS related systems or new functionalities in existing systems e.g. EDMS, CAPA, QMS, etc.
- Implementation of new standards and regulations
- Co-hosting external audits
- Perform QMS trainings of the organisation
- Perform internal audits and audits of subcontractors and distributors
- CAPA handling
- Vigilance reporting
- Ensuring document control
- QA input and act as QA reviewer in development projects
We are looking for someone with a passion for efficiency, simplicity, structure and compliance and understand the challenges of working in a fast-growing environment. You should have worked with quality and regulatory in a medical device company, preferably class III products. Basically, you have thorough understanding of MDSAP, ISO 13485, AIMDD, MDD and MDR.
To succeed in your role, you are an outgoing and positive team player with drive who can work structured and independent, planning and defining your own work, but also work in cross functional projects with your colleagues.
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.
Welcome with your application!
This recruitment is handled by our recruitment partner, Moveup Consulting AB. To apply, please send your CV and a cover letter to firstname.lastname@example.org
If you have questions regarding Oticon Medical or this open position, please contact Ann at 0733-44 09 00. We are screening applications continuously. Please send your CV and cover letter no later than 16th of January.
By submitting your application, you also consent to us storing your personal data, including CV & cover letter and that we have the right to share this information with third parties (our client). You can revoke the consent whenever you want.
Oticon Medical is part of William Demant Holding with more than 8.000 employees across the world and revenues of over DKK 8 billion. Oticon Medical is the fastest growing manufacturer of bone anchored and cochlear implant hearing systems for children and adults. At Oticon Medical we combine more than a century of experience in audiology and sound processing from Oticon with decades of pioneering experience in hearing implant technology. Our connection to Oticon gives us unique access to knowledge, resources and technology that we use for developing innovative and life-changing implantable hearing