Quality Technician

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Category: Quality

Location: 34501 - EMS FERMOY IRE - Fermoy, CO IE (Primary)

JOB TITLE: Quality Technician

DEPARTMENT: Quality Department

REPORTING TO: Quality Operations Lead

About Sanmina Fermoy:

Our Fermoy, Ireland, facility is FDA registered and certified to 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.

OBJECTIVES OF POSITION:

• To ensure customer satisfaction by monitoring, controlling, and improving all related customer processes. Customer interface for Quality metrics and improvement initiatives.

RESPONSIBILITIES:

• Support quality process definition, set up, verification, and improvements.
• Complete in-process testing on product.
• Complete weekly leak & burst testing on product to ensure product is sealed correctly as per the required specification.
• Verification of the Critical process parameters (CPP`s) & Line Clearance activities.
• Conduct internal process audits to ensure conformance and effectiveness of the Quality System.
• Support audits by demonstrating product testing requirements & best practices.
• Feedback and improvement on Customer 'Supplier Quality Issues'.
• Prepare for and attend daily engagement process meetings.
• Identify improvements through Quality review and meetings on Quality, Yield, flow, documentation, control, etc.
• Escalate Quality Issues where necessary & conduct non-conformance investigations when required.
• Perform weekly environmental monitoring sampling of the ISO Class 8 Cleanrooms.
• Prepare and review sterile release packs (Endotoxin & Bioburden test reports).
• Conduct and verify releasing of sterile product.
• Support SMT line first off verifications along with verifying line clearance activities.
• Review and approve unplanned maintenance activities when required across multiple assembly lines.
• Determine Lot suitability for release by reviewing production logs and final batch records against product specifications, procedures, and electronic data systems.
• Review and approval of Design History Records (DHR) by obtaining and verifying the contents of DHR's against the relevant documentation requirements.
• Interact with manufacturing execution system (MES) & Oracle Agile systems daily to ensure products are assembled as per the required specification.
• Ensure workspace compliance to Site requirements, ESD, MSD, Housekeeping (5S), Safety, etc.
• Assure ongoing compliance with quality and industry regulatory requirements.
• Ensure compliance with Health & Safety Legislation and Regulations.

MEASUREMENTS:

• Yields at Key Process Steps ("Critical Quality Attribute" Stations).
• Accuracy and consistency of record collection.
• Adherence to GDP & GMP practices.
• Completion of tasks/projects against set objectives in performance review.

PERSONNEL SPECIFICATIONS:

ESSENTIAL:

• Minimum NFQ Level 6 Certificate / Diploma in Science or Engineering, or sufficient job-related experience.
• Sound understanding and utilization of problem-solving techniques.
• Proficient in the use of MS Word, Excel, and PowerPoint.
• Good communication and influencing skills.
• Ability to write standard operating procedures and training documents.

DESIRABLE:

• Experience in a similar Quality role in the electronics manufacturing industry.
• Experience in working within a Medical Device Manufacturing Environment.
• Six sigma Green or Black Belt certified.
• Experience in New Product Introduction Processes.