Our client a Manufacturing company based in the Munster region requires a Quality Engineer. This is a permanent role to be based in Cork. The job involves ensuring customer satisfaction by monitoring, controlling and improving all related customer processes and to be responsible for the principal customer interface for quality metrics and improvement initiatives.
Key Responsibilities of the job:
- Identify, plan and organize regulatory affairs for ensuring compliance with the FDA's Quality System Regulations as well as all international standards relevant to customer products for the manufacturing facility.
- Generation and Review of KPI / Key Quality Metrics and have the overall responsibility for DMR/DHR and Technical Files.
- The QE will be responsible for data collection, analyzing and reporting, initiate
- Continuous Improvement programs, NPI Approval including First Article Inspections and Reporting and have good statistical background.
- CAPA, Customer Complaints, NCM, RMA analysis and Improvement.
- Prepare and execute Validation protocols. (IQ, OQ & PQ).
- QE will conduct Internal Audit
- Customer Audits, Yields at Key Process Steps.
- The Quality Engineer will focus on Customer Satisfaction (CCN, CSO, VOC etc.), Customer Return % and Cost (RMA) and Scrap %
- Outgoing Inspection DPM & Customer Incoming Quality Lean.
Education, Experience and Skills:
- Third level Degree in Science, Electronics, Mechanical or Industrial Engineering.
- At least 3 years Quality Assurance / Regulatory affairs experience in a similar Quality Engineering role in electronics manufacturing or Medical Devices.
- A good understanding of Quality and Regulatory requirements related to the Medical Devices Industry.
- Sound understanding and experience in Quality Planning, FMEA, Control plans, DOE and Statistical analysis.
- Ability to effectively analyze data and present information to management, internal personnel and customers at all levels.
- FDA Audit Experience.
- Experience in Process Validations as per CDRH guidance, Six sigma Green or Black Belt Certified and experience in a New Product Introduction Processes
For further information on this job please contact Cliona O'Malley on 091730022 /firstname.lastname@example.org
Please Note: HERO Recruitment will not forward your details to any company without your prior approval.