A Design Assurance Engineer is required by CareerWise Recruitment for our Galway based Medical Device client. If you are interested in position in exciting projects in a Small to Medium Sized company then this is the position for you !!!
Role of this position
- Act as 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 clients 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.
- Ensuring that all work satisfies the requirements of the company's Quality
- 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.
- Degree in Bachelor's Degree in Science or Engineering background
- 3-5 years of medical device design and development/quality assurance experience is required.
- Familiarity with FDA QSRs, medical device regulations and ISO 13485
- Experience using an electronic quality management system (eQMS) is desirable.
- Lean or Six Sigma certification/experience is desirable.
- Auditor experience is desirable (i.e. Supplier, Customer, Third Party, Quality Management System (QMS))
Please call Louise Mulligan today for further information on 0949003979 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)