Quality Engineering - Senior - Contract
| Reference: | AMII-510415 |
Location: |
Limerick
|
| Qualification: | Degree | Experience: | 5-7 Years |
| Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
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)
- Excellent interpersonal and communication skills
- 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.
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
If you would like further information you can contact:
Alexa Tralla | Tel: +353 (0) 1 507 9255
PLEASE APPLY DIRECTLY BY CLICKING HERE
Twitter | Linkedin
Under the Data Protection Acts 1988 and 2003, your details will be kept confidential and will not be passed to a third party without your express prior consent.
Science Recruitment | Engineering Jobs | Science Jobs
Pharmaceutical Jobs | Medical Device Jobs | Clinical Research Jobs | Biotechnology Jobs