Design Assurance Engineer

Location: Galway, Republic of Ireland Salary:
Sector: Medical Devices Type: Permanent

I'm working with a medical device company in Galway for the opening of a Design Assurance Engineer. The company hold a portfolio of 13,000 products and are at the forefront of the medical device industry. Their presence in Galway extends almost 25 years and continues to be one of the most highly respected medical technology leaders in Ireland.

The Role:

  • Work closely with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
  • Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
  • Identify and resolves complex exceptions to work assignments, while improving products and process quality.
  • Provides both quality and technical input to ongoing product development and post market commercial product activities.
  • Experienced in post market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).
  • Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
  • Excellent analytical and problem solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.
  • A vital team player who is willing to coach others in their areas of expertise.
  • The majority of the work will be spent on-site in an office environment with the occasional requirements to work in a test lab and/or cleanroom manufacturing environment.
  • There may be a requirement as part of the role to travel to other sites.

Qualifications & Experience:

  • HETAC Level 8 (240 credits) in a STEM discipline with a minimum of 1 year experience in a similar role.

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