Device Quality Officer (f/m/d)
Updated: 11 Jul 2022
Offered by:ten23 health AG
- You are an experienced Device Quality leader, familiar with the biopharmaceutical industry preferably from a service provider (CDMO) perspective, as well assterile product manufacturing and testing, Device assembly, testing, Quality engineering expertise, and quality skills and mindset.
- You enjoy starting up new businesses and have a track record in building relationships, and scaling business processes
- You have strong technical background in Device Quality infrastructure, compliance and systems, Device Engineering, incl EU MDR, CE marking, relevant ISO Standards, and FDA cGMP requirements for Combination Products
- You have experience with pharmaceutical sterile production for clinical and/or commercial products, device assembly of autoinjectors, finger flange, needle safety devices and plunger rod insertion and device functionality testing
- You want empowerment and are self-organized, self-prioritizing, effective in a start-up environment, with growth mindset and business acumen, and able to think and act outside the box.
YOUR KEY ROLE ASSIGNMENTS
- Developing and overseeing the implementation of all Quality Assurance activities for Device assembly and testing
- Responsibility for Device Quality infrastructure, compliance and systems and responsibility for Quality Assurance for all our GMP operations, including GMP manufacturing, assembly, and Device testing, either performed internally or externally (subcontracted)
- Leading and collaborating with peers and colleagues
- Collaborating with partners and vendors
- The role will be part of our Quality Circle, place of work is Basel/Switzerland or Visp and Remote as required, with high work- flexibility.
- Transparency in all we do, no bureaucracy and as less hierarchy as possible
- Purpose driven, value based and servant leadership
- Highly engaged, talented and passionate colleagues throughout the entire company where empowerment and diversity are crucial elements for success
- Our contracts are indefinite, salaries fair and competitive and you will be participating in the companies’ equity
- We drive a robust fairstainability agenda and we promote part time work
You want to k more about that…… contact us and find out!
- Your CV with all relevant career steps, education, and other activities
- What resonates with you when reading our job posting?
- What roles do you have adays in your life?
- What are you passionate about and what is your personal purpose in life?
- What are your typical characteristics and what are your strengths?