1. About Medace

Too many promising medical innovations never reach the market or the patient. One of the hurdles to take is finding your way through the ever more stringent and difficult landscape of medical devices (ISO, MDR) and cell therapy (GMP) legislation and technical validation.

Medace offers a full-service work-learning environment where customers (being academics or entrepreneurs) are guided in how to set up and develop the technical dossier needed for clinical validation whilst producing their clinical grade product. Medace works according to an ISO 13485:2016 certified quality and service package available for our customers on a use by need basis.

Medace provides:

  • Specialized infrastructure (e.g. ISO7 and 8, and Class C and B cleanrooms)
  • Validated and specialized equipment
  • Quality Management System
  • Trained professionals for hands-on guidance and support during development and validation
  • Dedicated in-house training programs

For more information: www.medacespace.com

  1. Description of Role

The Quality Manager Medical Devices (MD), is responsible for planning and executing the daily quality assurance activities regarding Medace’s ISO13485 certified QMS as well as the planning, strategy and coordinating of the quality support activities for our medical device clients. He/she ensures the compliance and staying up-to-date with international quality requirements as defined by the applicable ISO guidelines, MDR and IVDR regulations in the specialized area of MD.

  1. Position in the organization

The Quality Manager MD works side-by-side with the Quality Manager GMP. The Quality Manager MD also works side-by-side with the Operations team (Manager Facilities and Technical Engineering, Operations and Logistics Manager and Biosafety Officer) for effective alignment regarding quality-operational tasks. The Quality Manager MD reports together with the Quality Manager GMP to Top Management on the effectiveness of the QMS and any need of improvement.

  1. Responsibilities
  • Leading and advising the multi-disciplinary teams (Clients) in regulatory processes;
  • Hands-on support for the Clients in quality processes, e.g. FMEA, Document (Control) Plan and execute quality assurance activities (document management, batch records and label issuance, batch record review, equipment and supplier qualifications etc.) including documentation (advise, review and approve);
  • Monitor compliance with all applicable ISO standards and MDR/IVDR regulations;
  • Write, review and approve documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests, etc.);
  • Heads the Quality Circle, a soundboard group meeting with quality representatives of our clients (role together with Quality Manager GMP);
  • Lead coordinating internal and conducting of (according to the ISO19011)/external audits;
  • Coordinating, conducting and tracking Regulatory Training (MD/IVD);
  • Developing training materials and applicable tests and guides;
  • Managing and overseeing the developments and needs within the Quality team, the effectiveness of the QMS and Client QA-support activities;
  • Back-up for the Quality Manager GMP
  • Be a trusted partner for Top Management to determine best solutions, help drive alignment and implement decisions throughout your team (as Management Representative for MD).
  1. Education
  • At least (HBO/HBO+) degree in biomedical related area
  1. Experience / knowledge
  • At least 2+ years of expertise in QA/RA in the field of MD/IVD
  • Experience with setting up and maintaining Quality Management Systems
  • Experience in coordinating and conducting internal audits
  • Experience in lead auditee during external audits
  • Developing training materials and applicable tests and guides
  • Experience in Risk Management processes
  • Knowledge of quality systems, ISO certification (ISO 13485) in the biomedical/regenerative medicine field
  • Knowledge of MDR/IVDR related to medical devices and in-vitro diagnostics
  • Knowledge of GMP would be an add on
  1. Skills/Profile
  • Independent thinking and planning ability
  • Initiator
  • Multitasker
  • Training skills;
  • Good teamwork skills, as well as the ability to work independently.
  • Excellent command of English, spoken and written (HBO/HBO+);
  • People management
  • Customer focused/oriented
  • Good communication skills
  • Problem solving skills
  • Mentoring skills
  1. What do we offer?

We offer you a young and dynamic company with a team of enthusiastic employees, dedicated to support clients in their mission to bring new solutions to patient and market. The Medace model is one of a kind and has also been recognized and awarded as such. You will be able to develop yourself to the fullest and pioneer with the team to pave the road. This is a fulltime position (1.0FTE) but parttime (0.8FTE) is acceptable. Position in first instance for a year, with outlook to a permanent position. Wages and labor conditions are market conform.

  1. Information and how to apply?

If you have questions regarding the position please contact Kurt Gielen by mail (kurt.gielen@medacespace.com) or phone (+31 6 1927 1669). Applications can be send to info@medacespace.com.