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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. 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 9001, ISO 13485, ISO 14001 and PDML Japan as well as any international standards relevant to customer products for Sanmina Ireland Unlimited Company manufacturing facility. 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. 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. Microbiology point of contact for audit support for internal, customer and regulatory inspections in Sanmina Ireland UC as required. 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.
Job Responsibility:
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 & PQ)
Conducting Audits to ensure conformance and effectiveness of the Quality System
Develop and continuously improve system and procedures to assure quality of incoming material
In collaboration with our end customer and the materials department, utilize a closed loop Supplier Corrective Action Process in conjunction with scorecard reviews to improve supplier performance
Support for 1st Article Inspection of material
Supplier assessment, audits and quality improvement
Supplier rating and trend reporting
MRB analysis and follow up
Departmental Processes & Procedures
Generation of key performance controls as part of Quality Metrics System
Appropriate support for other Quality Engineering areas as required from time to time for holiday or absence cover
Determines lot suitability for release by reviewing production logs and final batch records against product specifications, procedures and electronic data systems
Reviews and approves Design History Records (DHR) by obtaining and verifying the contents of DHR’s against the relevant documentation requirements
Confirms deviations and notifies the Batch Release Lead and account management team of product release issues by providing feedback immediately upon discovery of potential stop ship situations
Audits processes and procedures and the work of others through examination, inspection, measurement, and Good Documentation Practices (GDP) / Good Manufacturing Practices (GMP) to ensure conformance and effectiveness of the SANMINA quality systems
Assist with general Admin duties within ADC Quality Team
Prepare for and attend weekly engagement process meetings helping to identify and initiate improvement projects through the use of effective and current continuous improvement tools
Requirements:
Minimum Level 7 Degree/ Diploma (Preferably in a Biotechnology, Microbiology, Science, Electronics, Mechanical or Industrial Engineering)
Proficient in the use of MS Word, Power-point and Excel
Ability to write standard operating procedures, training documents, and regulatory responses is preferred
Ability to respond to common inquiries or complaints from internal customers and regulatory agencies
Flexibility to Travel
Experience in Cleanrooms (ISO Class 8),is preferred
Sound understanding and utilization of Problem Solving Techniques
Good communication and influencing skills
Nice to have:
Ability to write standard operating procedures, training documents, and regulatory responses is preferred
Experience in Cleanrooms (ISO Class 8),is preferred