Lean og Validering, Six Sigma

ID1023

Pharmaceutical and medical device Compliance

Senior consultant, Medical Device, Production Engineer, B.Sc.
Available for: Full time, part time, tasks

Competences

  • Engineering projects related to Medical Device Industry.
  • Project management, planning and implementation.
  • Compliance (Pharmaceutical and medical device business).
  • Vendor & contract management.
  • Data and trend analysis.
  • Risk assessments/analysis & Risk based approach, FMEA Trouble shooting/Root Cause Analysis.
  • DMAIC (Six Sigma).
  • Lean/ PPI – Practical Process Improvement.
  • Process mapping/analysis

Key results

  • Establish drug handling production facility/flow.
  • Implementation of FDA+ISO compliant IT system (maintenance).
  • Implement new program and processes for preventive maintenance, validation and calibration.
  • Restructuring of laboratory facility and related processes.
  • Change management transformation of low performing dept. to high performing department.
  • Introduce and roll out Lean Program across European production sites.

Software/Standards

Certifications:

  • ISO13485 – Lead Auditor Training –IRCA Certified.
  • Prince2 – Foundation + Practitioner Certification.
  • Lean Navigator / Six Sigma Black Belt Certified

Regulatory: Thorough knowledge of:

 

  • ISO 13485+21 CFR 820 (Quality Management System & Requirements).
  • ISO 14971 (Risk Management)

Personal Characteristics

He is characterized as a structured technical oriented project manager/ process consultant with a can-do attitude who finds energy “in getting things done”.

Focusing on creating value for the business where both the target and the means are crucial to the success of the delivered.

Primary strengths is the profound ability to interact and engage with people on all levels in the organization.
In addition to this he is known for being a good communicator who approaches challenges in a pragmatic and solution-oriented way.

Spare time is used on sports, outdoor living + family and friends.

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