A medical device company in Galway is looking for both level I and level II Quality Engineers to join their team.
There are contract and permanent roles available, and the ideal candidate understands and complies will all the regulations governing the quality systems.
Responsibilities as a Quality Engineer
- You will possess the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
- You will participate in Customer Complaints investigation for areas under their control.
- You will continually seek to drive improvements in product and process quality.
- You have knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, make appropriate decisions on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
- You are knowledgeable on Risk Management, BSEN 14971 requirements.
- You will comply and analyse operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
- You may have to participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements.
- Have knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
- You will provide technical guidance to Associate Quality Engineer, Technician, and Inspection staff.
- Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
- You will deal with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
- You are familiar with the internal auditing process.
- Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
Requirements and Experience:
- NFQ Level 8 qualification in a Engineering / Science or related discipline.
- 2-3 years’ experience in a Quality Engineering capacity.
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Proven ability to work well both as part of a team but also able to work on own with minimum supervision.
To apply for this position, contact Rebecca O’Connor at Sigmar Recruitment T: +353 91 479265, or email roconnor@sigmar.ie .
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