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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 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.
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