Working within the Quality function, this role will involve identifying and implementing improvements within a high volume, fully automated manufacturing environment.
You will be responsible for analysis, identification and implementation of manufacturing and/or business process improvements which will improve capability and performance.
Prior experience of SPC and statistical analysis tools is essential.
The successful candidates will
- Have demonstrated experience and implementation of using Lean Manufacturing, Six Sigma, or similar analysis tools
- Proven track record of implementing projects
- Use appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques)
- Degree qualified in a relevant Engineering or Science discipline (Manufacturing, Mechanical, Electronic, Production etc) with a minimum of 5-7 years relevant experience
- Proven track record of implementing Six Sigma and/or Lean Continuous Improvement projects
- Experience within Medical device industry is desirable but not essential.
- 5 years’ experience in a regulated environment
- SIX SIGMA – Certification
- Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA)
- Experience of the design and qualification documentation standards to current FDA expectations
- Knowledge of statistical packages and Microsoft Office systems required
- Proven ability to review and critique Quality Critical technical documents
- A good understanding and working knowledge of FDA and ISO regulations
- Knowledge of lean manufacturing
- Five years’ experience as Quality Engineer working in a cGMP environment preferably in medical device
- Self-Motivated - requires minimal direct supervision.
- Must have good written and presentation skills and be able to communicate effectively throughout organization
- Demonstrated Experience working with data base applications desired
- Ability to set priorities while ensuring compliance is not compromised
- Experience in performing Design of Experiments (DOE) and leading