Job Description DEPARTMENT: Quality REPORTING TO: Quality Lead About Sanmina Fermoy Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO*****:**** for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices.
Sanmina Fermoy's core specialization is manufacturing automation.
We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing The Quality Graduate will rotate between areas of the quality department.
These will be Quality Engineering, Quality Engineering Supplier Quality, Quality Engineering Microbiology and Quality Engineering Batch Release.
Quality Engineering: To ensure customer satisfaction by monitoring, controlling and improving all related customer processes.
Customer interface for Quality metrics and improvement initiatives.
Identifies, plans, and organizes regulatory affairs for ensuring compliance with the FDA's Quality System Regulations, ISO ****, ISO *****, ISO ***** and PDML Japan as well as any international standards relevant to customer products for Sanmina Ireland Unlimited Company manufacturing facility.
Quality Engineering Supplier Quality: To ensure the quality and integrity of incoming material for one of our key medical customers thereby maximising yields and minimising production fails and scrap.
Quality Engineering Microbiology: Ensure customer satisfaction by monitoring, controlling and improving cleanroom related customer processes.
Customer interface for Cleanroom performance and biological, sterilisation, bioburden and endotoxin results.
Quality metrics and improvement initiatives.
Perform laboratory testing and assigned laboratory duties so that timely viable testing can be performed on site in addition to non viable testing.
Provide guidance in the area of cleanroom performance, microbiology laboratory activities and biological testing to the Quality Technicians in the area.
Quality Engineering Batch Release: Confirm that all production records are in compliance with Sanmina's quality system, whilst ensuring the effective and timely approval of all Batch Release related processes and procedures prior to verification.
Provide batch release support to the manufacturing process by helping to ensure delivery of the highest standards to the customer whilst continuing to strive for continuous improvement.
Track, Review and report out on weekly Batch Release Metrics.
Responsibilities: Quality Engineering: 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.
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