​What you need to know

An innovative and growing medical device company in Co. Roscommon who provide their clients with bespoke and high-quality medical device products is currently seeking a Quality Assurance Engineer.

The Quality Assurance Engineer will report to the Quality Engineering Manager.

This is a permanent position, working week is from Monday – Friday.

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Your new job

Key duties & responsibilities.

• Follow company policies and procedures strictly.

• Have a deep understanding of company products and processes.

• Adhere to the Quality and Environmental Management System requirements.

• Review, update, and maintain current quality management processes and procedures.

• Keep precise quality records, analyse data, and manage documentation.

• Achieve KPIs to support the business in reaching its objectives.

• Assist with plant projects, ensuring key deliverables are met on time and communicating effectively with both internal and external customers.

• Offer quality support to designated customer and project teams, ensuring compliance with customer and QMS requirements to meet GMP standards.

• Lead Quality Engineering tasks for product lines, including creating product inspection plans, production documentation, process FMEAs, and risk management plans.

• Lead and coordinate the execution of process and product validations.

• Investigate quality issues and implement effective corrective actions.

• Ensure quality inspection instruments are accurate, regularly calibrated, tested, and audited.

• Assist in maintaining the company’s ISO accreditation.

• Conduct internal and external audits as needed.

What are we looking for?

• Possess a Level 8 or equivalent degree in Quality Assurance or a related field.

• At least 3 years of experience in a Quality Engineering role, with hands-on experience on the manufacturing floor, preferably in the medical device industry.

• Skilled communicator within multi-functional teams, capable of managing internal and external customer requirements.

• Proficient in Microsoft Office.

• Familiarity with Syspro, Minitab, and Lotus Notes is preferred.

• Knowledgeable in ISO 13485, ISO 14971, and QSR 21 CFR Part 820 standards.

• Strong expertise in statistical analysis techniques for problem-solving and quality improvement.

• Ability to plan, organize, and prioritize daily tasks.

• Proven ability to drive projects to successful completion.

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Benefits.

• Company pension.

• Healthcare.

• Gym membership.

Apply for this job now by sending in a Word version of your CV or get in touch with Eugene at eugene@matrixrecruitment.ieor alternatively by phone at 0874075822. 

By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and permission. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position.

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