About Us. A valued and trusted partner to the world’s leading companies. We are committed to service excellence through our talented people who are empowered to be innovative and best in class. Location. Based at Ireland’s southwest coast, Cork is home to a large university with pharmaceutical and medical device hubs across the county. From sports, culture and activities Cork has so much to offer! Join us and work with us to deliver the excellent service we are renowned for with our clients. Be part of something great. Your Job Purpose. Working with the LotusWorks team as a Quality Engineer, you will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. Responsibilities. Conducts assignments encompassing complete projects or portions of major projects. Determine methods and techniques to be used or adapt standard methods to meet variations. They coordinate phases of work internally and externally. Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs. Conduct benchmarking to develop more effective methods for improving quality. Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management. Utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. Support processes in base business. Supports new product introduction as part of design transfer. Approve IQ, OQ, PQ, TMV or Software Validation. Requirements. Bachelor`s Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred. Five years’ experience as Quality Engineer working in a cGMP environment preferably in medical device. SIX SIGMA – Certification. Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA. Experience of the design and qualification documentation standards to current FDA expectations. Knowledge of statistical packages and Microsoft Office systems required. Proven ability to review and critique Quality Critical technical documents. A good understanding and working knowledge of FDA and ISO regulations. Desirable. Knowledge of lean manufacturing. Benefits. Life Assurance. Pension Contribution. Training & Educational Assistance (Engineers Ireland CPD Members. Healthcare Contribution. Annual GP Check-Up. Extra Annual Leave. Healthcare Screening. Not ready to apply, or have some questions? Call our Talent Specialist’s on +3537191-69783 or Email email@example.com and we will be happy to help! LotusWorks is proud to be listed in the Best workplaces 2017. Empowering talent we care about for over 29 years. LotusWorks is an Equal Opportunity Employer. This job originally appeared on RecruitIreland.com.
158 days ago