ID1040
Senior QA Auditor and QA Lead Expert
BSc, Food Science and Technology
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
- Quality management & Management representative.
- PRRC (MDR) & EU authorized rep.
- Customer and Supplier contracts.
- Lead auditor (+400), Internal & Suppliers, ISO9001, 13485, MDSAP, MDR. TGA, 21CFR820, CMDCAS, QMS optimization.
- Supplier control and qualifications (SQM & SCAR).
- Audit readiness & preparation process.
- Management Reviews.
- QMS Implementation.
- Cleanroom monitoring and Microbiology evaluation.
- Due Diligence, Company Acquisition.
- Due Diligence, New Suppliers
- Reviewer Validation, Tech. files, Risk Management documentation, CAPA handling.
- Audit facilitator, customers, authorities etc.
- Leading organizations through changes.
- Holistic understanding of the full company value chain.
- Finding robust, pragmatic solutions to complex issues.
Key results
- Mid to Executive QA Management Roles within the last 15 years within an international FTSE 100 Medical Device Company.
- +400 Lead audits (world) – ISO 13485, ISO 9001, ISO 14946, MDSAP, MDD, MDR, ISO 11135, ISO 14649, GMP, ISO 14644.
- Year by year certification (13485) International FTSE 100 Medical Device Company.
- Facilitating 3 FDA inspections without critical outcomes.
- MDR transition, SteerCo member and QA resp. for timely deliveries. Int. MD Company
- Successful MDSAP implementation, International FTSE 100 Medical Device Company
- Auditing of world’s largest MD companies (acted as outsourced process) as Quality responsible building new cleanrooms (ISO class 8) in three facilities.
- QA Due Diligence responsible, potential company acquisition for Medical Device Company.
Software and Standards
Extensive knowledge in:
-
EU Harmonized/ recognized standards
ISO 13485, MDSAP, ISO 14971, ISO 14644, ISO 2859, ISO 9001, ISO 11135, ISO 19011, ISO 22000, ISO 14946, ISO 14698 etc. -
FDA regulation
CFR 21 part 820, part 11 – QSIT & QSR -
EU Regulations
MDD 93/42/EC, MDR 2017/245 -
MEDDEV Guidance 2.12/1
-
Others
HACCP, BRC (food), ISF (Food), FSSC22000 (Food safety) -
Software recent experince
MS Office suite, Lotus Notes, Trackwise, Visio, Concur, SAP, MS Team
Personal Characteristics
He is a highly experienced and respected top level international Quality Leader, that through the last 15 years have led the Quality organizations (+30 FTE), within a devision of a FTSE 100 Medical Device company.
He comes with a very positive and pragmatic mind-set that find it easy to make relations to other persons and teams, no matter role and position in the organization.
Private he is enjoying the time with family and friends. He loves live music, outdoor living that includes fishing & camping. He is furthermore crazy about F1 and football.
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