Senior Quality Engineer
Our client, a medical device company in Galway are currently looking to recruit a Senior Quality Engineer for their site.
- The Senior Quality Engineer position is one of creation and innovation, if you pride yourself on your problem solving skills, meticulous attention to detail and organisation skills this may be the role for you. You will be tasked to provide quality engineering support in design and development of medical device products, specifically ventilators. In addition you will facilitate the application of design controls in product development and sustaining changes, the successful application will also provide support in the rapid resolution of product complaints and/or safety issues.
- As a Senior Quality Engineer you will review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. You will ensure design changes to existing products are conducted in compliance with the FDA Quality System Regulations Design phases. You will participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, con-conflicting and feasible product requirements that support the market needs. You will also participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report). Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report. You will assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance. You will provide guidance and direction for sample size and statistical analysis of verification and validation test results. Experience Statistics stools experience an advantage e.g. Minitab. You will provide training to project teams on procedures, verification, validation, statistical methods and design controls. You will review Design History Files and Technical Files for conformance to applicable requirements. You will assist, when appropriate with internal and supplier audits.
- We are looking for a qualified person to Third Level BEng/BSc Level 8 qualified with at least 5-7 years' experience in a manufacturing organization. Strong familiarity with regulatory requirements (e.g. ISO 13485, CFR 820 & EN ISO 14971), Experience in risk evaluation techniques, e.g. HHE/HHA, Product Risk Assessment, SFMEA/HHA, DFMEA, PFMEA & fault tree analysis. Risk Management, ISO 14971, FTA, FMEA, HACCP. Familiarity with Hardware ME Design & Development: Stack Up and Tolerance Analysis, Key Inspections Analysis Material Analysis, Design of Experiments & Reliability Analysis. Preferred requirements: Medical Device/Healthcare Industry experience, Familiarity with EN ISO 60601-1, EN ISO 60601-1-8, EN ISO 80601-2-12 a distinct advantage. Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing and ANOVA desired. Test plan development and root cause failure analysis. Previous Quality Auditor experience is desirable or certification is an advantage Experience in Design Quality is desirable.
- Leadership Expectations provide the framework for what we expect from all employees at our company - outlining the actions and behaviours we must develop and demonstrate in pursuit of our Mission and global growth goals.
- We are committed to being experts in what we do, with a clear vision of where we are going and the plan to get there.
- Demonstrates Global Business Acumen
- Thinks Critically and Makes Sound Decisions
- Sets Strategic Direction
- We partner with and involve others, knowing that diverse talent, skills, and perspectives lead to better outcomes.
- Collaborates and Creates Alignment
- Attracts, Deploys, and Develops Talent
- Fosters Diversity and Inclusion
- We are bold thinkers who create new ideas and bring our best solutions forward to benefit our patients, partners, and customers.
- Focuses on Patient and Customer
- Generates Breakthrough Ideas
- Initiates and Leads Change
- We do what we say we are going to do, delivering results with the highest standards.
- Sets High Standards
- Instils Operational Excellence
- Drives Accountability
- Models Ethical Behaviour
For further information on this Senior Quality Engineer role in Galway please contact Bimi Felix on 091730022 / email@example.com
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