Quality Engineer – Projects – 9 months
About your New Employer:
This is a well-established global medical device company with 30 years of history in Galway. This employer is dedicated to providing meaningful assistance to patients by providing top-class medical equipment, especially in the cardiovascular area.
These roles are within the Project Team (Structural Heart) and Line Support (Centralised Sterilisation & Packing).
About Your New Job as a Quality Engineer:
* Involvement in validating new equipment in the manufacturing area (experience with NPI & validations required).
* Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system.
* Understands and complies with all the regulations governing the quality systems.
* Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
* Identifies and resolves complex exceptions to work assignments.
* Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process-related findings.
* Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
* Participates in Customer Complaints investigation for areas under their control.
* Continually seeks to drive improvements in product and process quality.
* Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decisions on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
* 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.
* Knowledgeable on Risk Management, BSEN 14971 requirements.
* Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
* May participate directly in a new product/technology transfer to ensure compliance with all internal and regulatory requirements.
* Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
* Maintains relationships and gives technical guidance to Quality Technicians across different shifts.
* Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
* Deals with suppliers, other engineering disciplines within and outside of the Site, and customers should the need arise.
What Skills You Need to Succeed as a Quality Engineer:
* A Level 8 Degree (240 Credits) or equivalent in a STEM discipline.
* A minimum of 3+ years’ relevant experience, ideally within the Medical Device industry or another highly regulated environment.
* Familiar with Internal Audit Processes.
* We would like you to be a team player and someone who is fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
What’s on Offer for Candidates for a Quality Assurance Engineer:
* Salary of up to 35e per hour DOE.
* Paid Holidays.
* Fantastic career development opportunities.
What’s Next:
* Apply now by clicking the “Apply Now
#J-18808-Ljbffr