Lean og Validering, Six Sigma
Pharmaceutical and medical device Compliance
Senior consultant, Medical Device, Production Engineer, B.Sc.
Available for: Full time, part time, tasks
- 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
- 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.
- 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)
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.