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Quality Assurance Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 22851

Our client an exciting start up medical device company developing a new and innovative device to support the heart are looking to hire a Quality Assurance Engineer as they grow operations.

This is a Permanent onsite role based here in Galway.

The Role:

As the QA Engineer you will have strong knowledge of Quality system processes for medical devices with the aim of gaining ISO 13485 certification. You will support the development of the quality system and ensure ongoing medical device quality control for the business. You will work closely with the team to problem-solve and proactively recommend solutions that improve the QMS, overall quality performance and compliance.

Responsibilities:

  • Implements, manages, and controls updates to Quality Management System documents while ensuring their accuracy, quality, and business agility.

  • Collaborates with cross-functional teams to support the development and approval of changes to the QMS.

  • Ensures company document changes meet procedural requirements and submits feedback to owners, as needed.

  • Supplier set up within QMS. Ensures that supplier quality documents are approved in a timely manner and follows up with process owners, as needed.

  • Provides Supplier Quality compliance guidance to team.

  • Support for 1st Article Inspection of material, Supplier assessment, incoming inspection, audits, and corrective action as required.

  • Provides metrics status to management for QMS and Supplier Quality related topics for Management review.

  • Supports external/internal Quality System and supplier audits.

  • Provide training on Quality best practices and QMS processes.

  • Supports regulatory submission documentation compilation and engages with external consultants to complete submission package.

Requirements:

  • Qualification in quality or STEM discipline.

  • Previous experience in quality systems engineering, quality assurance, supplier quality or a similar role.

  • Experience using quality assurance software tools (eQMS) and processes.

  • Strong communication and interpersonal skills.

  • Strong analytical and problem-solving skills.

  • Experience of working effectively in team environments.

For more information and a confidential discussion on the role, please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 70671