Quality Engineer with 3-5 years’ experience in a Quality Assurance environment required for permanent role in the midlands. Reporting to the Quality Manager, the successful candidate will be responsible for initiating, recommending, verifying and providing solutions to prevent the occurrence of any non-conformity related to the product, process and the quality systems.
- Investigation of production issues, containment & analysis.
- Customer complaint evaluation, analysis, reporting and timely closure.
- Complaint trending and monitoring of corrective actions.
- Control of Non-Conforming Material Review.
- Maintenance & communication of GMP standards throughout the plant.
- Development, issuance and implementation of QA documentation.
- Liaise with superior and other functional supervisors routinely.
- Participate in the development, validation and implementation of the manufacturing processes and equipment for existing and new products.
- Manage / execute site quality systems including CAPA, internal and supplier auditing, product release and validation activities.
- Lead Problem Solving, Failure & Root Cause Analysis, Risk Assessment & FMEA activities within the Team.
- Adherence to regulatory standards including ISO 9001, ISO 13485, FDA 21 CFR Part 820
- Delivering in-house training on quality assurance concepts and tools.
- 3rd level Qualification in Quality / Science / Engineering
- A minimum of 3-5 years’ work experience in a Quality Assurance environment is required.
- Thorough knowledge and understanding of manufacturing systems and solid working knowledge of processes and products.
- Excellent communication skills – both written & verbal and interpersonal.
- Computer literate (e.g. Microsoft Word, Excel, Internet, Email).
- Self directed and results driven team player with excellent communication skills.
- Lean/Six Sigma Training an advantage.
- Exceptional problem solving and analytical skills with the ability to make quick and appropriate decisions. Proficient at multitasking and prioritizing.
- Candidates from a Medical Device background will have a distinct advantage.
- ISO 9001 and/or ISO 13485 knowledge.
- Internal Auditor Training
Please contact Emer Moore to discuss in confidence