Are you interested in taking the next step in your career with a leader in medical science?
Are you ready to challenge yourself in a fast-paced and high-regulated environment?
Are you an experienced engineer with a background in quality and validation?
You could be the perfect candidate for this opportunity!
Don't hesitate, apply today!
Job Description Our client is seeking an experienced Quality Engineer who has proven success in quality and validation activities.
You will provide quality support for site activities, ensure compliance with standards and collaborate with cross-functional teams.
The ideal candidate will have experience in quality assurance and will have the ability to communicate effectively.
You will be responsible for maintaining quality systems and continuous improvement initiatives.
Key Responsibilities:Identifies and resolves complex exceptions to work assignmentsHas the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming productContinually seeks to drive improvements in product and process qualityKnowledgeable on MDR and QSR standards, constantly promoting awareness of best industry practices, making appropriate decisions daily utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisionsFully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaintsEvaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effectsCompiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processesMay participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirementsUses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve qualityPossesses excellent collaboration skillsGives technical guidance to Quality Technicians.
Requirements:A Level 8 Degree or equivalent in an Engineering or Science-related disciplineA minimum of 2 years' experience working at Engineering level, ideally within the Medical Device industry or similar highly-regulated Experience with internal and external audit processesA team player, who can demonstrate best practices in line with the department and site objectives and someone who is fully motivated to achieve.
BenefitsCompetitive and attractive employee compensation packagePension contributionsHealth insurancePaid public holidays.
Location: Galway, Ireland | onsite