Senior Quality Engineer
Senior Quality Engineer – Galway. Key Responsibilities. • Select appropriate techniques for problem solving and make solid and consistent Engineering and Quality Assurance recommendations. • Have the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product. • Participate in Customer Complaints investigation for areas under your control. • Demonstrate and actively promote highest levels of professional QA engineering discipline and rigour. • Be viewed as a leader in the areas of QSR and ISO/MDD standards within your group, constantly promoting awareness of best industry practices, making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decisions. • Have significant expertise in validation engineering and be thoroughly familiar with all regulatory requirements. • Review and approve operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes. • Champion continuous improvement and innovation from a quality perspective within the department right from vendor selection/approval through to customer awareness/satisfaction. • Be an effective team member, fully motivated to achieve and demonstrate best practices in line with the department. • Give technical guidance to Quality Engineers, Associate Quality Engineers, technician and inspection staff. • Be familiar with the internal auditing process. Qualifications and experience requirements: • Minimum Degree (level 8) in a relevant discipline. • Minimum of 6-8 years’ experience in medical device or a similar industry. • Good technical capabilities, communication skills, teamwork abilities and initiative. • Proven ability to work well as part of a team & on own with minimum supervision.
29 days ago