Quality Engineer - Senior
Independent Solutions
Limerick
Our client based in Limerick is seeking the following for a 39 week contract: 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: o Have demonstrated experience and implementation of using Lean Manufacturing, Six Sigma, or similar analysis tools. Proven track record of implementing projects. o Use appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques. o Excellent interpersonal and communication skills. o 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. o 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. This job originally appeared on RecruitIreland.com.
2526 days ago