Quality Assurance and Regulatory Affairs

ID1007

Senior QA Expert

MSc. Product Management, University Albstadt 
Available for: Part-time, full-time

Competences

  • Project Management
  • Executive Management, Strategy
  • Quality Management Systems ISO 9001, ISO 13485
  • Design Control and MDR transition
  • Clean Room, Health and Hygiene and ETO-Sterilization
  • Process-and sterilization validation
  • Risk Management, FMEA
  • Complaint Management
  • Change Management
  • Internal and supplier audits
  • Management of Non-conformites, CAPA
  • Communication with Authorities
  • Post Market Surveillance
  • Quality assurance sample testing, test plans•Coordinate measurement systems (Multi sensor)
  • NiTinol materials (shape memory alloy)

Key results

10+ years maintenance and evolution of QMS from start-up to mid size company and strategy change from contracted manufacturer to direct sales company.

Several successful sterilization validation projects with external customers.
Successful ISO 13485: 2016 implementation along with implementation of risk based approach for key processes.
CE registration and international registration of various class IIa and IIb devices.
Successful PLM certification audit class III cardiovascular medical devices.
Successful company registration audit (GMP) of Brasil National competent authority.

Software/Standards

  • Medical Device Directive & Regulation.
  • ISO 9001
    – Quality Management
  • ISO 13485
    – Medical devices
    – Quality Management
  • ISO 14971
    – Medical devices
    – Risk management
  • ISO 11135
    – Sterilization of health-care products
    – Ethylene oxide
    – Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 11607-1; -2 Packaging for terminally sterilized medical devices
    – Part 1: Requirements for materials, sterile barrier systems and packaging systems.
    – Part 2: Validation requirements and processes
  • ISO 14644
    – Cleanrooms and ass. environments
  • ISO 10993
    – Biological evaluation of medical devices.

Personal Characteristics

He has a wide range of Quality Management and Regulatory skills by his education and one and a half decades of hands-on and management experience.

He knows how to develop, implement and follow up a company- and QMS-strategy by his experience as executive board member.
He also understands the various needs of single departments, how cooperation in inter-departmental team structures works and how interfaces need to be be set up to meet stakeholders needs.

His distinct customer orientation drives him to find pragmatic and cost-effective solutions.

In his free time he is a passionate father and scuba diver. Following his diving passion, he is voluntarily active rescue diver and rescue and recreational diving instructor at German water rescue organization DLRG.

Contact

Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com