Quality Engineer

DEPARTMENT: Quality Department

REPORTING TO: Quality Engineering 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 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 FDA’s Quality System Regulations, ISO 9001, ISO 13485 , ISO 14001, PDML Japan Quality Management, as well as any international standards relevant to customer products for Sanmina manufacturing facility.

RESPONSIBILITIES:

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.

Assure ongoing compliance with quality and industry regulatory requirements.

Ensure compliance with Health & Safety Legislation and Regulations.

MEASUREMENTS:

Yields at Key Process Steps.

Customer Satisfaction Index, (CCN, CSO etc).

Customer Return % and Cost (RMA).

Scrap %.

Outgoing Inspection DPM & Customer Incoming Quality Levels.

PERSONNEL SPECIFICATIONS

Minimum NFQ Level 7 Degree/ Diploma in Science or Engineering, or a lesser qualification with sufficient job related experience.

At least 2-3 years Quality Assurance / Regulatory affairs experience. In a similar Quality Engineering role in the electronics manufacturing industry is preferred.

Proficient in the use of Microsoft Word, Power-point and Excel.

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.

Experience in working within a Class 3 Medical Device Manufacturing Environment is preferred.

Six sigma Green or Black Belt Certified is preferred.

Experience in New Product Introduction Processes is preferred

Core Competencies:

Sound understanding and utilization of Problem Solving Techniques.

Good Communications and influencing skills.