Description
Prior experience of SPC and statistical analysis tools is essential.Other Skills, Experience and Education
- 5 yrs 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.
Desirable
- Knowledge of lean manufacturing
- Five years experience as Quality Engineer working in a cGMP environment preferably in medical device.
- Positive attitude
- Continuous Improvement orientation
- Accepting of change
- Flexible - Calmly reacts to the unexpected
- Credible - Accountable for decisions
- Self-Motivated - requires minimal direct supervision.
- Results focused - maximizes business benefit from all activities.
- Innovation - thinks laterally but within a compliant framework.
- Organized - Able to cope with extensive documentation and planning requirements.
- Six Sigma or quality engineer certified,
- Structured problem solving and decision making skills working in a team environment.
- Ability to participate in or leading cross functional project teams
- 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