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|Location:||Wexford, Kilkenny, Carlow|
Hartley People are currently recruiting for an experienced Quality Engineer. Our client are a renowned, progressive manufacturing company based in Co. Wexford.
- Provide Quality Engineering representation on Product Development Teams.
- Initiate new/revised documentation and tracks through approval cycles and implementation.
- Participate on cross-functional teams to develop risk assessment.
- Develop physical and functional test methods to ensure specifications are met.
- Write and/or review design verification and validation protocols and reports.
- Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.
- Conduct and/or coordinate testing outlined in protocols and test methods.
- Perform process improvement, control and monitoring on manufacturing processes.
- Provide technical direction during design transfer activities.
- Conduct complaint investigations.
- Participate and provide input to training on department/division procedures and policies.
- Participate in project planning, budgeting, scheduling and tracking.Participate in internal and supplier audits.
- Develop and implement procedures to provide easy to follow instructions.
- Understand and follow company procedures on regulatory requirements.
- Provide positive example and actively promote compliance to all standards.
- Min Engineering or Science degree required.
- Min. 2 years experience in medical device industry or similar industrial environment with good working knowledge of regulatory requirements and Quality Systems techniques.
- Experience in risk-based decision making and problem-solving.
- Knowledge of design validation, design transfer and change control principles and techniques.
- Knowledge of statistical methods and Six Sigma process excellence tools.
- Knowledge of risk management principles and techniques.
- Knowledge of pre-production QA principles and techniques (e.g. APQP, PPAP, MSA).
- Knowledge of supplier qualification and management principles and techniques (incl. auditing techniques).
- Knowledge of project management fundamentals and tools.
- Advanced computer systems skills (MS Office software, databases and statistical software).
- Good teamwork capabilities, effective reporting.
- Fluent English communication skills (business English written and oral).
- Strong Analytical Capabilities.
Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent.
For immediate consideration please call Pairic on 051-878813 or email your CV in response to this job posting.
Hartley People also recruit for similar roles such as Analytical Chemist, Quality Control Manager, Quality Control Technician, Quality Assurance Manager, Quality Assurance Technician, New Product Development Manger, Quality Systems Manager, Formulation Scientist, Development Technologist.