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Design Assurance Engineer

  • Sector: Engineering
  • Contact Email: christopher.otoole@collinsmcnicholas.ie
  • Job Ref: 19789

Our client a major multinational here in Galway are looking for a Design Assurance Engineer on a permeant basis. This is a hybrid working role.


As our newest member of our clients Design Assurance team, you will demonstrate commitment to the Quality Policy (patient safety and product quality) by executing sound quality practices and maintaining an effective quality system. The key to the success of this function is to fulfil the quality assurance responsibilities of our client’s new product development and post-market (commercial product) support, including the application of Design Controls in Product Development and Sustaining Changes to ensure that all design changes are compliant with associated Regulations and Methods. 

We are looking for individuals that share a passion for innovation and advancing solutions for some of the world’s most challenging healthcare issues.  

 

Key Activities of the Role:

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.
  • Evaluate trending and product performance to support site-level Signal Evaluation Reviews and Complaint Review Boards
  • 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 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 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 our client’s new product development and post market (commercial product) support.
  • Coaches others in areas of expertise. Gives technical guidance to junior team members. Uses opportunities in project assignments to develop self & others.
  • 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 and Experience:

 

  • NFQ Level 8 qualification in a STEM discipline
  • Minimum of 3-4 years experience in a must
  • Experience in post-market (complaints) support, risk management, design and process change, and standards compliance (to regulatory requirements) is highly desired.
  • Good technical capabilities, communication skills, teamwork abilities and initiative
  • Proven ability to work well both as part of a team and work on your own with minimum supervision

 


For more information or a confidential discussion about this role please contact Christopher O Toole

christopher.otoole@collinsmcnicholas.ie

091 706713