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Design Assurance Engineer

Real Staffing Group

Posted on Nov 10, 2020 by Real Staffing Group

Sligo, Ireland
Engineering
Immediate Start
€40k - €40k Annual
Full-Time


Job title: Design Assurance Engineer


Location: Finisklin, Sligo


Benefits:



  • 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


Company:


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.


Responsibilities:



  • 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


Requirements:



  • 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

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