Design Assurance Engineer
Posted on Nov 10, 2020 by Real Staffing Group
Job title: Design Assurance Engineer
Location: Finisklin, Sligo
- Benefits: Opportunity to grow your career,
- Annual Salary - mid €40k
- Occupational Company Pension Scheme
- Health Insurance
- Continued Professional Development Support
- Educational Assistance
- Annual Leave service increment
- Subsidised Sport & Social Club
- Bi-annual Company events
- Employee Wellbeing Programme of Events
My client is a Medical device engineering company offering a range of development and manufacturing services from initial design assessment, through to the provision of sterile finished product for the European and US medical device market.
- Assist with the development of quality evaluation and control plans and protocols for processing materials into finished products.
- Work closely with product development engineering team and the client to establish design specifications and product requirements
- Issue of Product paperwork/lot records to manufacture and also review and release of same and compile COA/COC;
- Support QMS as Quality Coordinator in the investigation into non-conformances,
- Quality review of cGMP documentation, SOP's, WI's, templates etc. to ensure compliance to all applicable regulatory standards and cGMP procedures and practices
- Quality review of responsible area validation documentation of Design & Development Documents
- Liaise with suppliers and customers on quality related issues;
- Participating in design reviews and the compilation of associated documentation
- Assist Head of Quality in implementing and maintaining the QMS
- Conduct internal audits, including closing out audits in a timely manner, creating audits finding reports and determine proper corrective and preventive actions
- Drive continuous improvement and best practices in QMS "Right First Time".
- Updates job knowledge by participating in educational opportunities
- Minimum Degree in a Science or Engineering discipline.
- 3-5 Years' experience working in a medical device environment in a Design Assurance Engineering role, (preferably with involvement in product design and R&D).
- Strong knowledge of ISO 13485, FDA regulations 21CFR 820.
- Internal/external auditing experience would be an advantage.
- Validation experience including Sterilization, process and packaging validations would be beneficial.
- Knowledge of Medical Device manufacturing environment including cGMP would be an advantage.
- Permanent Contract. Start Date; ASAP. Full time
If you are interested in hearing more about this role or know of anyone who might, email or call and I am happy to discuss further with you.
Look forward to hearing from you.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales