Cork Quality Medical Device jobs

JOB TITLE: Graduate Quality Engineer

DEPARTMENT: Quality

REPORTING TO: Quality Lead

About Sanmina Fermoy

Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO13485:2016 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.

We hire people with a range of skills, experience, and backgrounds to fulfill roles in careers such as engineering, quality and manufacturing to name just a few.

Objectives;

• 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.

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.

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.

#Sanmina

Job Type: Graduate

Ability to commute/relocate:

• Kilworth, County Cork: reliably commute or plan to relocate before starting work (required)

Work authorisation:

• Ireland (required)

Work Location: In person