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OssDsign
OssDsign is a developer and global provider of next generation bone replacement products. Based on cutting edge material science, the company develops and markets products that support the body’s own healing capabilities and thereby improve the clinical outcome in a wide range of orthopedic areas with high medical needs. With a product portfolio consisting of patient-specific implants for cranial surgeries and an off-the-shelf synthetic bone graft for spine surgeries, OssDsign give back patients the life they deserve.
For more information, visit the company´s web sites at www.ossdsign.com
Head of Quality Assurance and Regulatory Compliance
Job Title: Head of Quality Assurance & Regulatory Compliance
Reports to: Vice President Operations and R&D
Location: Uppsala, Sweden
OssDsign is looking for a Head of Quality Assurance & Regulatory Compliance that will be responsible for OssDsign’s Quality Management System and for maintaining its effectiveness and to provide expertise in Quality Assurance by participating in the day-to-day operation related to the design, manufacture and supply of their medical devices. The person will act as the Person responsible for regulatory compliance (PRRC) and as the Management Representative.
This is a full-time position at OssDsign, based at the office in Uppsala. The position reports to the Vice President Operations and R&D.
Profile
We are looking for a highly skilled and motivated Head of QA & Regulatory Compliance with at least 5 years´ quality management experience within the medical device industry and with very good communication skills together with strong attention to details and quality focus, to be able to deliver in this important role. It is also important to be a person that can work with a sense of urgency and having the ability to be unbiased and objective. The person needs to be able to take decisions and having the ability to work across different teams, and good time management to drive performance.
Experiences and qualifications
• M.Sc. in Engineering or Chemistry or equivalent or other University degree and with experience from a similar position
• A solid experience from Quality Assurance within the Medical Device industry
• Understanding of Quality Management Systems and the need for regulatory compliance for Medical Device development and manufacturing (ISO 13 485 and QSR)
• Training in QMS and correlated ISO standards
• Experience of audits by competent authorities (FDA) and notified body
• Fluent in English and Swedish, oral and written
• Experience of product release is an advantage
• Management experience is meritorious
• Experience of working in and/or implementing an electronic Quality Management Systems is a merit
• Experience of development and/or manufacturing within Life Science is a merit
• Experience of implant is meritorious
• It´s a merit with an PhD
Competencies
• Ability to work independently, and effectively cooperate with different local and global teams
• Ability to take decisions
• Structured with the ability to logically organize thoughts and ideas
• High level of self-motivation with the ability to operate independently and with minimum supervision when required
• Pedagogical and provides others with a clear direction regarding the importance of quality management
• Good communication, writing, and presentation skills in Swedish and English
• Strong attention to details and quality focus
• Good time management and meeting deadlines and commitments
• Ability to prioritize and manage multiple tasks
• Ability to handle challenges
• Positive “can-do” attitude and a “doer”
Opportunities with the role
• To contribute to OssDsing´s very important mission; to give patients back the lives they deserve and to improve their quality of lives
• The possibility to work for a very exciting Swedish Life Science company with a high growth rate and a huge potential to grow
• The possibility to work with very high quality, innovative and unique products that the patients are asking for
• OssDsign offers continues development for all personnel, both individual and team oriented
• Work together with an experienced and very committed team, in a creative and very prestigeless environment
• The company culture is very attractive with a focus on community and development
• Be part of a successful expansive and dynamic company focusing on research, innovation and results, committed to give patients back the lives they deserve
• To work with a broad spectrum of responsibilities, and to contribute with your expertise
• This is a key position, with the great opportunity to build, lead and develop the quality organization for the company to secure success in the future
Contact
For more information and questions about the position, please contact Marta Frick Senior Recruitment Consultant at PeakSearch.
Contact details:
Marta Frick marta.frick@peaksearch.se Tel: 070-386 89 69