Quality Engineer (Medical Device)
Quality Engineer (medical device) - Co. Offaly. Reporting to the Quality Manager, you 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. Key Responsibilities: • 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. Essential requirements for this position: • 3rd level Qualification in Quality / Science / Engineering with 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. Desirable: • 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. • Projects a strong professional image and able to interact within all levels of the organization. • Lean Six Sigma Green Belt Certification or a willingness to gain such certification is desirable. This job originally appeared on RecruitIreland.com.
100 days ago