Job Overview
Sanmina Fermoy, Ireland, facility is FDA registered and ISO 13485:2016 certified for manufacture of high‑quality PCBAs, subassemblies and Class III medical devices.
Job Title
Quality Technician
Department
Quality Department
Reporting To
Quality Operations Lead
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 (CPPs) & line clearance activities.
* Conduct 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 release 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 DHRs 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.
* 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.
Essential Qualifications
* 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 Qualifications
* 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.
Job Location
Fermoy, County Cork, Ireland
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