This Job Vacancy has Expired!

Design Assurance Engineer

Real Staffing Group

Posted on Nov 10, 2020 by Real Staffing Group

Sligo, Ireland
Immediate Start
€40k - €40k Annual

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.

Position Details

  • 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

Reference: 1001079151

Set up alerts to get notified of new vacancies.

Similar Jobs

Design Assurance Engineer

Sligo, Sligo County, Ireland

Annual Salary