Collins McNicholas

Summary

Currently looking for a Quality Engineer or Senior Quality Engineer.  Your role will be to support the Quality Manager in ensuring that all product released by the company for human use meets the company’s product quality requirements, and to ensure that product is manufactured, released and distributed in accordance with the regulatory requirements outlined below.

Principal Responsibilities

  • Support the finished device manufacturing subcontractor and stent supplier to ensure that the company’s product quality and regulatory requirements are met.
  • Perform lot review and lot release activities.
  • Support the operations group to ensure that product manufacture and release activities meet business needs.
  • Review and contribute to process validation and risk management activities of the subcontractor and stent supplier.
  • Support Operations, subcontractors and suppliers in implementing process improvement and lean initiatives.
  • Ensure that SCAR’s, CAPAs, NC’s and other open action items, are completed in a thorough and timely manner.
  • Assess and process supplier and company changes, ensuring product impact is appropriately considered.
  • Provide QA support for post product release supply chain activities, e.g. at the company’s storage facilities, distribution hub, distributors etc.
  • Plan, execute, report and follow-up on subcontractor and supplier audits.
  • Track and report progress across projects by reviewing schedules and due dates, identifying risks and assisting teams with contingency plans.
  • Support the Complaint Coordinator in evaluation/investigation of product complaints.
  • Support R&D and Design Assurance in development activities.

 

Education & Training

  • Educated to a Minimum Diploma Level in an Engineering, Science or Quality Assurance discipline.
  • Auditing Qualifications are desirable.

Experience

  • A minimum of 3 years’ manufacturing quality or quality systems experience is required (5-7 years for Senior QE), ideally in a Medical Device manufacturing environment
  • Experience of managing relationships with subcontractors and suppliers is preferred.
  • Experience in performing process validation and risk management activities is required.
  • Excellent attention to detail, communication skills, project management skills, people and team working skills.
  • Excellent problem-solving skills
  • Experience in ISO 13485; 21 CFR 820; and MDD as well as Quality Management Systems.
  • CAPA, Auditing and Risk Management experience per ISO 14971 (including FMECA)

For a confidential discussion and more information on the role, please contact Stephen Kelly on 091-706714.

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