Senior Design Quality Engineer
Our client, a medical device company in Westmeath are currently looking to recruit a Senior Design Quality Engineer for their site.
- Further, Together Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let's work together to address the universal he...
- Together, we will change healthcare worldwide. Join us in our Mission to alleviate pain, restore health and extend life worldwide. Let's work together to address the universal healthcare needs and improve patients' lives, optimize costs and efficiencies, and expand global access. Together, we can make a real difference in the global disparity in care. By providing quality care at the lowest possible cost, we will succeed as a company, and take the future of healthcare Further, Together.
- The Senior Design Quality Engineer position is one of development, improvement and innovation, if you pride yourself on your problem solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality engineering support in design and development of medical device products, Airways, Breathing Circuits and Inhalation. Facilitate the application of design controls in product development and sustaining changes. Provide support in the rapid resolution of product complaints and / or safety issues.
- As a Senior Design Quality engineer, your key responsibilities will involve, reviewing new and modified product designs for quality characteristics - including manufacturability, serviceability, and testability, reliability, and product requirements. You will ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations. You will participate on cross-functional teams to develop product risk management files (risk management plans, risk assessments, dFMEA, and risk management reporting). You will assist in the creation of verification and validation test plans, protocols and reports, while overseeing testing and analysis for standards and product requirements compliance. You will ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
- We are looking for a qualified person to Third Level Degree (BSc) in Mechanical Engineering or related discipline with 5 years' experience in a similar role. Good verbal and written communication skills including protocol / report development and technical presentations. You have experience Risk Management ISO 14971, and Experience of Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis. You have experience of design verification &validation test plan development and root cause failure analysis. You have a working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. The following are desirable and not mandatory: You are familiar with the statistical software tools (Minitab, stat graphics, and statistical). You have knowledge of stability, biocompatibility, sterilization & ship testing knowledge. You have a DFSS / Lean Green Belt or Black Belt. You are familiar with IEC 60601, ISO 5361, ISO5366, and product specific industry standards. You will be open for travelling as part of the job (5-10% travel requirements) this position will be based out of Athlone with Global interfaces / support.
- 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
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