The company: As a medical device company, we help people in a truly tangible way.
We are one of the most modern electronics factories, which gives us the opportunity to develop and build a career working with the latest technologies.
The knowledge and skills you'll gain here are unique, and you'll find new challenges and endless opportunities along the way.
Our Fermoy, Ireland, facility is FDA registered and certified to ISO for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices.
Sanmina Fermoys core specialization is manufacturing automation.
The facility has a track record of 30 years of outstanding operational performance and customer service, backed by a highly experienced workforce.
Benefits: Healthcare Pension plan On site parking Subsidized Canteen Recognition & Service Awards Maternity pay Wellness Initiatives EAP Program Flexitime hours OBJECTIVES OF POSITION: Primary objective is to ensure customer satisfaction by monitoring, controlling and improving all related customer processes.
Principal customer interface for Quality metrics and improvement initiatives.
Identifies, plans, and organizes regulatory affairs for ensuring compliance with the FDAs Quality System Regulations, as well as all international standards relevant to customer products for Sanmina manufacturing facility.
RESPONSIBILITIES: Quality support to manufacturing line including but not limited to: Investigating potential nonconformances (Material and Process) Complete Event Investigations Disposition of nonconforming material/product Management of closed loop customer complaints and improvement processes.
Generation and Review and review of Quality Metrics System.
Overall responsibility for DMR/DHR and Technical Files.
Generation and approval of SOPs Quality Plans, FMEAs and control plans.
Data collection, analyzing and reporting.
Pareto and trend analysis.
Initiate and drive Continuous Improvement programs.
NPI Approval including First Article Inspections and Reporting.
CAPA, NCM and RMA analysis and Improvement.
QSR Validation protocols and report (IQ, OQ & PQ).
Conducting Audits to ensure conformance and effectiveness of the Quality System.
Deputize for the Quality Engineering Lead where appropriate.
Plan and implement procedures and systems to maximise operating efficiency.
Manage and contribute to the achievements of department productivity and quality goals Participate in regulatory agency inspections Support the management of the Event Investigation forum and required best practice problem solving techniques including weekly Yield data gathering and monitoring on selected accounts as required.
Support Weekly Customer reports as well as Quarterly Business Reports and data presentation when required PERSONNEL SPECIFICATIONS ESSENTIAL: Minimum NFQ Level 7 Degree/ Diploma inScience or Engineering, or a lesser qualification with sufficient job related experience At least 5 years Quality Assurance / Regulatory affairs experience.
In a similar Quality Engineering role in the electronics manufacturing/ medical device industry.
Sound understanding and utilization of Problem Solving Techniques Proficient in the use of Microsoft Word, Power-point and Excel.
Good Communications and influencing skills.
Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
Ability to write standard operating procedures, training documents, and regulatory responses.
DESIRABLE: Experience in working within a Class 3 Medical Device Manufacturing Environment.
Six sigma Green or Black Belt Certified Experience in New Product Introduction Processes