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Senior Quality Assurance Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 22629

Our client based in Oranmore Co Galway are looking to hire a Senior Quality Assurance Engineer as they expand operations.

The Role:

The Senior Quality Assurance Engineer is responsible for implementing and promoting best in class quality assurance through the product lifecycle.

Responsibilities

  • Responsible for compliance with quality systems procedures.

  • Is viewed as the leader in areas of quality systems ISO13485 standards and 21CFR Part 820 compliance.

  • Champions continuous improvement and innovation in the quality system, developing and improving procedures and systems for efficient compliance.

  • Lead and coordinate the internal audit program and ensure that Internal Audits are completed to schedule.

  • Lead interactions with FDA and with certification bodies in relation to QMS auditing, certification, and changes. Act as audit lead for any inspections/audits.

  • Collect and analyse quality system data for reporting across the organization.

  • Manage the complaint handling and corrective and preventive action process.

  • Support and coordinate improvement programs including conducting CAPA analysis to determine root cause and complete problem resolution.

  • Support the preparation and conduct of External Audits

  • Lead compliance and continuous improvement QMS related projects.

  • Conduct education and training with team members to on quality system requirements. 

  • Keep up to date on compliance best practices and constantly seek to improve compliance and efficiencies in line with best practices.

Requirements:

  • Degree in Quality Assurance, Quality Engineering or similar qualification,

  • Minimum 5 years’ experience in a relevant role in the medical device industry,

  • Broad experience of Medical Device Quality Management Systems, including electronic QMS systems.

  • Experience in CAPA system management,

  • Experience in Complaint handling systems,

  • Experienced in ISO13485 and 21CFR Part 820 FDA requirements and managing regulatory body audits,

  • Proven ability of working in a cross-functional team environment,

  • Knowledge and practical experience with the use of statistical techniques,

  • Training and experience in auditing (internal auditing, supplier auditing or similar),

  • Detail oriented with focus on implementing efficient systems for QMS Compliance.

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

michelle.mcinerney@collinsmcnicholas.ie

091 706717