Medical Devices JobsQuality Engineer – Medical Device

  • GY50321
  • Permanent
  • Galway

Collins McNicholas

Position: Quality Engineer – Medical Device Organisation, Galway

Requirement: For contract or perm

Purpose

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system.  Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

 Responsibilities

  • Identifies and resolves complex exceptions to work assignments.
  • Summarizes, analyzes, draws conclusions and makes appropriate decisions from test results or other process related findings.
  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of the non-conforming product.
  • Participates in Customer Complaints investigation for areas under their control.
  • Continually seeks to drive improvements in product and process quality.
  • Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making an appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
  • Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
  • Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
  • Knowledgeable on Risk Management, BSEN 14971 requirements.
  • Compiles and analyzes operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
  • May participate directly in a new product/technology transfer to ensure compliance with all internal and regulatory requirements.
  • Uses knowledge of Six Sigma, Statistical Analysis, and Lean principles to investigate and solve problems and improve quality.
  • Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
  • Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
  • Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
  • Is familiar with internal auditing processes

Qualifications and Experience

  • NFQ Level 8 qualification in a STEM discipline
  • Minimum of 3-4 years experience in a Quality Engineering capacity.
  • Good technical capabilities, communication skills, teamwork abilities, and initiative.
  • Proven ability to work well both as part of a team but also able to work on own with minimum supervision.
  • Proven ability to work well as part of a team & on own with minimum supervision

Package

  • Base salary in line with your experience
  • Healthcare
  • Pension
  • Bonus

Please get in touch to find out more information; elaine.dolan@collinsmcnicholas.ie

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