Medical Device Validation jobs

JOB TITLE: Lab Quality Technician

DEPARTMENT: Quality Department

REPORTING TO: Laboratory Manager

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 perform final product release testing (FPRT) processes in a regulated laboratory environment. The technician is responsible for maintaining high standards of accuracy, documentation discipline, and compliance while supporting the laboratory team in achieving testing schedules.
• To ensure customer satisfaction by monitoring, controlling and improving all related customer processes.

RESPONSIBILITIES:

• Perform testing using a variety of analytical and testing instruments to support laboratory science requirements.
• Operate laboratory-based computer applications and equipment with basic proficiency.
• Maintain meticulous attention to detail to ensure accuracy and consistency in all testing and documentation.
• Accountable for personal actions and the verification of work performed by colleagues.
• Proactively identify potential risks and solve problems by following established guidance.
• Support cross-functional groups and assist in training fellow technicians as required.
• Manage individual schedules to ensure the timely completion of all assigned testing.
• Support quality process definition, set up, verification and improvements.
• Complete testing to ensure product is manufactured correctly as per the required customer specification.
• Conducting internal process audits to ensure conformance and effectiveness of the Quality System.
• Supporting Audits by demonstrating product testing requirements & best practices.
• Escalation of Quality Issues where necessary & conduct non-conformance investigations when required.
• Supporting SMT line first off verifications along with verifying line clearance activities.
• Reviewing & approving unplanned maintenance activities when required across assembly lines.
• 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, cGMP, ESD, Housekeeping (5S), Safety etc.
• Assure ongoing compliance with quality and industry regulatory requirements.
• Maintain a compliance mindset with strict adherence to cGMP and site quality standards.
• Ensure compliance with Health & Safety Legislation and Regulations and proactively identify safety improvements where appropriate.

MEASUREMENTS:

• Yields at Key Process Steps (“Critical Quality Attribute” Stations).
• Accuracy and consistency of record collection.
• Adherence to GDP & cGMP practices.
• Completion of tasks / projects against set objectives in performance review
• Timely completion of testing schedules.
• Accuracy and consistency of documentation and test results.
• Adherence to Quality and Health & Safety standards.

PERSONNEL SPECIFICATIONS

Qualifications and Experience:

• NFQ Level 6 or higher in a science related field, preferably with Laboratory based knowledge.
• Sound understanding and utilization of Problem Solving Techniques.
• Proficient in the use of MS Word, Excel and PowerPoint.
• Good communications and influencing skills.
• Ability to write standard operating procedures and training documents.
• Ability to complete detailed reports when Quality related events arise.
• Experience working in a laboratory setting with various analytical/testing instruments is preferred.
• Previous experience in a regulated environment requiring strict documentation discipline.
• Basic computer skills for operating laboratory applications.
• Previous medical device manufacturing experience is preferred.

Core Competencies:

• Experience in working within a Medical Device Manufacturing Environment.
• Experience in New Product Introduction Processes.
• Analytical thinking and structured problem solving
• Strong organizational and time management skills
• Commitment to compliance and continuous improvement.
• Meticulous attention to detail.
• Strong organizational and time management skills.
• Effective communication skills, including the ability to escalate issues promptly.
• Team-oriented and supportive of a collaborative environment.

#Sanmina

Job Type: Full-time

Work Location: In person