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 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 & test, shipping and repair. We create a state-of-the-art environment for manufacturing medical and other high-quality devices. The facility has a track record of 30 years of outstanding operational performance and customer service, backed by a highly experienced workforce.
DEPARTMENT: Quality Department
REPORTING TO: Quality Lead as defined by employment contract. Will be one of: Quality Engineering Lead/ Quality Lead - Supplier Quality Engineer/ Senior Manager Quality Systems
Individual Contributor or People Manager: Individual Contributor
Objectives;
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 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.
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.
- Microbiology point of contact for audit support for internal, customer and regulatory inspections in Sanmina Ireland UC as required.
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 & PQ).
- Conducting Audits to ensure conformance and effectiveness of the Quality System.
Quality Engineering Supplier Quality:
- 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.
Quality Engineering Microbiology:
- Generation of key performance controls as part of Quality Metrics System.
- Data collection, analyzing and reporting.
- Pareto and trend analysis.
- Initiate and drive Continuous Improvement programs.
- CAPA, NCM and RMA analysis and Improvement.
- Appropriate support for other Quality Engineering areas as required from time to time for holiday or absence cover.
Quality Engineering Batch Release:
- 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:
- Qualifications and Experience:
- 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
- Core Competencies:
- Sound understanding and utilization of Problem Solving Techniques.
- Good communication and influencing skills.
