stillingsbetegnelse: R&D Process & Compliance Manager

jobbeskrivelse:
Lokation DK - Smørum .Are you up for the challenge? Does the word accountability resonate with you and are you prepared to be accountable for our compliance? How would you like to have a role, where your expertise and contribution is actually valued and not frowned upon? Have you got the necessary skills and experience to further develop our quality systems? Then join us for one of the most exciting challenges within the quality area in the region, where you truly have the opportunity to make an impact! About the job The role is new and situated in our R&D department within the Hardware function. This team consists of mechanical-, electro-acoustic- and electronics engineers and project managers. With your strong background within process development and project management, as well as your profound knowledge and experience within Medical Device regulations, you guide and support project teams in setting up and tailoring milestones and documentation in accordance with requirements for medical devices. Your main tasks and responsibilities: Driving updates of QMS processes, Hardware checklists and templates Support HW R&D programs in tailoring processes and documentation in relation to quality standards and regulations Conduct documentation reviews to ensure the right quality for milestone reviews You are the “go to person” in Hardware with respect to quality issues and we expect you to contribute to a large extend to the further development of our quality processes and systems. Your background You probably have an educational background in engineering. Throughout your career, you have gained significant experience with process development and project management, in addition to knowledge about medical device regulations. More specifically, in order to achieve success in your new role, you probably have experience with the following: Medical Device quality Knowledge of - and experience with Quality Management Systems, Quality System Standards and QSR (e.g. ISO 13485, FDA CFR 21 Part 820) Training experience in quality processes and documentation Project management and leading multi-site teams Your personal competencies In order to succeed in this position, you need to thrive working independently and without too many guiding principles. Moreover, people see you as friendly, outgoing and collaborative, i.e. not a “quality control police officer”. Lastly, you are flexible, highly structured, possess a great overview and adaptable to changing circumstances. Do you want to join the team? Then send your application no later than November 21st. If you would like to learn more about the job, you are welcome to contact Head of Program Delivery, Henrik Thomsen: htho (at) oticon.com Please note that only applicants using our e-recruitment system are considered for the position. Therefore, do not send your documents via email, thank you. We look forward to hearing from you. About Oticon 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 1,300 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 William Demant Holding Group with more than 11,000 employees and revenues of over DKK 10 billion.

Arbejdsgiver Navn: OTICON A/S

Arbejdsgiver telefonnummer: 39177100

Arbejdsgiver faxnummer: 39277900

Job kort beskrivelse: Ingeniørarbejde i industri og produktion

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark