Quality Technician (12m FTC)

Sanmina; Fermoy; On-site; EUR 38,000 - 48,000; Full time

Benefits offered by this job

Shift allowances

Healthcare benefits

Job summary

Sanmina Fermoy in Ireland is seeking a Quality Technician on a 12-month fixed-term contract within the Quality Department. The role supports quality process definition, conducts in-process testing, and participates in audits to ensure GMP and GDP compliance.

You will monitor CPPs, perform weekly environmental monitoring in ISO Class 8 cleanrooms, review DHRs, and interact with MES/Oracle Agile systems to ensure products meet specifications. Shift-based days/nights.

Qualifications

• Minimum NFQ Level 6 Certificate / Diploma in Science or Engineering or equivalent.
• Ability to write standard operating procedures and training documents.
• Sound problem-solving techniques and attention to detail.

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 proper sealing.
• Verification of CPPs and Line Clearance activities.
• Conduct internal process audits to ensure GMP/GDP compliance.
• Prepare for and participate in daily engagement process meetings.
• Review and approve Design History Records (DHR) contents.

Skills

Problem-solving

Communication skills

SOP writing

Education

NFQ Level 6 Diploma in Science or Engineering

Tools

MS Word

Excel

PowerPoint

Job description

• Please note that this is a shift-based position (12-hour shifts which include days and nights inclusive of weekends). A competitive basic salary + shift allowances and benefits package provide!

Job Description

JOB TITLE: Quality Technician (12m FTC)

DEPARTMENT: Quality Department

REPORTING TO: Quality Operations 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 fulfil roles in careers such as engineering, quality and manufacturing to name just a few.

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.
• Conducting internal process audits to ensure conformance and effectiveness of the Quality System.
• Supporting 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.
• Escalation of 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).
• Conducting & verifying releasing of sterile product.
• Supporting SMT line first off verifications along with verifying line clearance activities.
• Reviewing & approving 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.
• Interacting with manufacturing execution system (MES) & Oracle Agile systems daily to ensure products are assembled as per the required specification.
• Work space 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.