Medical Devices JobsDesign Assurance Engineer

  • GY50263
  • Permanent
  • Galway

Collins McNicholas

Leading Medical Device organisation in Galway seeking an experienced Design Assurance Engineer

Role Purpose

  1. Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality
  2.  Understanding and complying to the company’s quality, business, health & safety systems and market/legal regulations governing the quality systems.
  3.  Removing or mitigating against risks associated with the design, use and manufacture of company devices.
  4.  Ensuring commitment to training requirements and understanding and complying with all regulations governing their work.

 

Key Responsibilities:

General

  1.  Completes work assignments under limited supervision/guidance.
  2.  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.
  3.  Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
  4.  Identifies and resolves complex exceptions to work assignments.
  5.  Seeks to support improvements in product and process quality.
  6.  Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
  7.  Excellent interpersonal and communication skills with good leadership abilities.

 Technical

  1.  Provides both quality and technical input to ongoing product development and post-market commercial product activities.
  2.  Experienced in post-market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).
  3.  Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
  4.  Excellent analytical and problem-solving abilities. Analyses draws conclusions and makes appropriate decisions from risk management activities and test data.

 Leadership

  1.  Is an active team member completing quality deliverables associated with the company’s new product development and post-market (commercial product) support.
  2.  Coaches others in areas of expertise. Gives technical guidance to junior team members. Uses opportunities in project assignments to develop self & others.
  3.  Is a fully motivated team member – achieves and demonstrates best practices in line with set objectives.
  4.  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:

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

Package

  • Salary DOE
  • Full Healthcare
  • Pension
  • Bonus

Please get in contact on elaine.dolan@collinsmcnicholas.ie for more information

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