Design Assurance Engineer
Galway

Contract
Our client’s Galway facility is a leading international manufacturing site, established in Ireland over 30 years ago. Since its inception, the site has grown significantly and now comprises a modern purpose-built 700,000 square foot facility, accommodating both manufacturing and R&D. Located on the outskirts of Galway city, the facility is unique within the organisation, producing products across three of the company’s primary product ranges.
Key Responsibilities
General
  • Completes work assignments under limited supervision/guidance.
  • Interfaces 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.
  • Identifies and resolves complex exceptions to work assignments.
  • Seeks to support improvements in product and process quality.
  • Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
  • Excellent interpersonal and communication skills with good leadership abilities.
Technical
  • Provides both quality and technical input to 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.
Leadership
  • Is an active team member completing quality deliverables associated with BSC’s sustaining engineering (commercial product) support.
  • Is a fully motivated team member - achieves and demonstrates best practices in line with set objectives.
  • Is willing to implement changes within the project/department practices and supports a culture of challenging the status quo to create best in class.


Qualifications & Experience
  • HETAC Level 8 (240 credits) in a STEM discipline with a minimum of 3-4 years’ experience in a similar role.
  • Good technical capabilities, communication skills, teamwork abilities and initiative.
  • Proven ability to work well as part of a team & on own with minimum supervision.