A Design Quality Assurance Engineer is required by CareerWise Recruitment for our Galway based client. As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected. As a Design Quality Assurance Engineer you will be responsible for assuring product quality, safety and effectiveness.
Role of this position
- As a lead Quality Engineer on projects, directly contributing and/or providing guidance to others to establish appropriate Design History File / Device Master Record documentation. Providing detailed planning for clinical, pilot production and scale-up plans in New Product Introduction programs.
- Ensuring project teams are utilizing the Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.
- Investigating and evaluating material biocompatibility and appropriate methods of sterilization during the product design cycle.
- Conducting risk assessments of the design to determine ability to function as intended.
- Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files (DHF), device master records, etc.
- Interacting with customer and supplier companies in a professional manner; proactively communicating with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.
- Intervening and contributing to successful resolution of technical issues when they arise.
- Ensuring that all work satisfies the requirements of the company's Quality Manual.
- Continually looking for improvement and compliance improvement opportunities.
- Leading Quality roles on client programs, assisting in the design and implementation of new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation.
- Maintaining detailed documentation throughout all phases of research and development, often leading documentation of user needs, product requirement and risk / test planning and execution activities.
- Conducting and/or participating in meetings directly with clients.
- Coordinating activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines. May include supplier qualification and management.
- Minimum Bachelor's Degree in Engineering or related field.
- 3 years Medical Device Design & Development/Quality Assurance experience required.
- Managing customer relationships and responses in aa timely manner.
- Ability to interact with client companies in a professional manner.
- Demonstrated ability to lead product verification & validation activities
- Experience working with operations to develop strong manufacturing process instructions and operator training is desired.
- Familiarity with process validation is required.
- Familiarity with FDA QSRs, Medical Device regulations and ISO 13485
- Familiarity with Metrology and ISO 17025 requirements
- Knowledge of probability and statistics.
- Organised and able to self-manage project tasks.
- Customer focus with excellent communication skills, written and oral.
- Depth of knowledge in one or more clinical areas.
- Depth of knowledge in one or more specialized areas, e.g. Biocompatibility, sterilization methods, etc.
- Experience using an electronic quality management system (eQMS) a plus.
- Lean or Six Sigma certification/experience preferred.
- Auditor experience preferred (i.e. Supplier, Customer, Third Party, Quality Management System (QMS))
- Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.