Quality Technician (24m FTC)

Sanmina Corporation; Fermoy; On-site; EUR 34,000 - 42,000; Full time

Job summary

Sanmina Fermoy in Ireland is seeking a Quality Technician (24m FTC) to safeguard product quality through in-process testing, CPP verification, and adherence to GMP/GDP standards.

You will join a busy Quality Department, support process improvements, audits, and release of sterile products, with 12-hour shift work including days and nights and weekend coverage.

Qualifications

• NFQ Level 6 Certificate / Diploma in Science or Engineering or equivalent.
• Strong problem-solving skills and ability to apply in QA.
• Proficient in MS Word, Excel and PowerPoint.
• Good communication and ability to write SOPs.

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 correct sealing.
• Verification of the CPPs & Line Clearance activities.
• Conduct internal process audits to ensure QMS conformance.
• 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.
• Escalation of Quality Issues where necessary & conduct non-conformance investigations.
• Perform weekly environmental monitoring sampling of ISO Class 8 Cleanrooms.
• Prepare and review sterile release packs (Endotoxin & Bioburden tests).
• Conduct & verify releasing of sterile product.
• Support SMT line first-off verifications along with line clearance activities.
• Reviewing & approving unplanned maintenance activities on multiple lines.
• Determine Lot suitability for release by reviewing logs and batch records.
• Review and approval of Design History Records (DHR) by verifying contents.

Skills

Problem solving

Communication

SOP writing

Education

NFQ Level 6 Certificate / Diploma in Science or Engineering

Tools

MS Word

Excel

PowerPoint

Job description

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Category (For Job Seekers)

Quality

Location

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

Job Description

JOB TITLE: Quality Technician (24m FTC)

DEPARTMENT: Quality Department

REPORTING TO: Quality Operations Lead

*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!

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:

• 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.