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Quality Assurance Engineer

  • Job reference: 930062
  • Location: Dublin
  • Salary: Negotiable
  • Job type: Permanent
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 18/02/2020

Orion Group Life Sciences have an exciting opportunity for a Quality Engineer for our Medical Devices client based in Dublin. This is a permanent role.


Main Responsibilities of the role

  • Support the development of their device as the company is early stage
  • Experienced will be needed in the areas of Medical Device Design, validation & regulatory approval
  • Work with a cross functional team of specialists to define the product to customer specification
  • Experienced with the development of test methods in an ISO 13485 environment
  • You will primarily responsible for product quality i.e. durability, usability, reliability, functionality etc.
  • Helps with auditing (internal and external)
  • Supports implementation & maintenance of a robust and fully compliant QMS in accordance with ISO 13485, including risk management
  • Strong exposure to GDP Practices in a regulated environment
  • Ensures adherence to all EHS policies onsite
  • A willingness to cross train" and/or mentor more junior employees
  • The role would be ideally suited to someone who enjoys autonomy & mentoring others on the job

Desired Experience and Background of the successful candidate

  • Minimum B.Sc. in a related Engineering area i.e. (Biomedical Engineering).
  • Other qualifications desired. (Post graduate qualification a significant plus.)
  • 3 years+ exposure to Quality Assurance Engineering in a regulated setting.
  • Class III medical product development experience preferred
  • Working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
  • Previous auditing experience preferred.
  • Work related travel may be required so be open to this.
  • Proficient with statistical techniques and the preparation of technical documentation.

#medicaldevice #validation #ISO13485 #FDA #audit #QMS

For more information on this role, call Colin on 353 (0)21 2063401 or email Colin.O'Donnell@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 930062


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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