Lean and Validation, Six Sigma

ID1020

Senior QA Validation Engineer

Process Technology and Chemistry
Available for: Part time

Competences

  • Qualification and validation (process/method/software).
  • Risk Management.
  • Process validation.
  • Software and Method validation.
  • Equipment qualification.
  • Six Sigma (trained master black belt).
  • Applied statistics.
  • QMS (procedures, templates, etc.).
  • Team management and coaching.

Key results

Extensive Medical Device experience, in particular within non-clinical test and validation disciplines, having worked both in planning, executing and reviewing (QA) protocols, statistical data analysis and reports.

Several post-warning letter remediation projects.
Recreation of lost component specifications.

Used for risk-and statistics-based rationalesand justifications for complex problems as well as effectiveness checks for CAPA’s.

Regulations/Standards/Software

Extensive knowledge in:

  • ISO13485:2016.
  • IVDR (In Vitro Diagnostic Regulation).
  • US FDA regulation 21CFR Part 820.
  • ISO14971 (Risk Management).
  • Certified Validation Manager.
  • Microsoft Windows.
  • Microsoft Office 365 (Word, Excel, PowerPoint, Outlook).
  • Microsoft project.
  • Microsoft Visio.
  • Minitab (statistical software).

Personal Characteristics

He believes that there will be a solution to every problem and will always strive to offer a feasible way onwards (or alternatives with pros and cons in cases where several viable solutions exist).

He is assertive by nature and will listen and look to data to offer the best way going forward, be it in a validation project, in writing up a lean QMS system or assessing the state of compliance and how to remedy any gaps.

He likes to keep up to date with new standards and regulations in the MedTech industry.
In his spare time he enjoys reading and spending time in his toolshop.

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