Our client, a global leader in medical devices is recruiting for a Quality Engineer for their site in Galway.
The Quality Engineer II is responsible for providing Quality Engineering input to support Design, Manufacturing and Operations. Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet the company, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing.
- 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.
- Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision 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 to all internal and regulatory requirements.
- Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
- Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
- Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives
- NFQ Level 8 qualification in a STEM discipline
- Minimum of 3-4 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.
- Proven ability to work well as part of a team & on own with minimum supervision.
- Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations; Ability to understand other medical device regulations and standards.
- Experience in nonconforming material and CAPA methodologies/systems preferred.
- Strong communication, presentation, facilitation, and project management skills.
- Experience working in cross-functional teams and driving projects to completion
- Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
- High sense of urgency and commitment to execution
- Applies continuous improvement principles in development of the quality system.
- Driven, energetic, self-assured professional with high personal integrity
- Knowledge of analytical techniques and statistical analysis
- Ability to develop effective, positive interpersonal relationship
For further information on this Quality Engineer role in Galway please contact Orla Crowley on 0860449473/ Talent@hero.ie
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