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Senior Quality Engineer | Co Galway

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 20211

My client a medical device company based in Co Galway are looking for a Senior Quality Engineer.


Responsibilities

  • Be the leader of Quality within assigned area. Act as the designate for the Quality Manager.
  • Continuously promote quality and customer satisfaction in everything that the company does. 
  • Ensure the Quality System is effective for the products being manufactured and fully compliant with customer and regulatory requirements.
  • Ensure all customer requirements are identified, clearly documented in company manufacturing documentation and effectively implemented.
  • Provide expert quality input into validations, change management, problem solving and product disposition activities.
  • Work with customers and suppliers on quality related issues and new product introduction projects. Ensure all dealings are professional and good relationships are maintained at all times.
  • Investigate product/process quality issues that arise, including customer complaints. Ensure they are effectively resolved in a timely manner using the CAPA system.
  • Ensure effective change control practices are implemented.
  • Lead quality related projects ensuring that they are delivered on time and within budget.
  • Be part of project teams. Deliver on commits to schedule and budget.
  •  Act as a Lead Quality Auditor. Perform Supplier Quality Audits. Act as a guide during customer and regulatory audits.
  • Be an expert on-site for statistical analysis and problem solving. 
  • Ensure that continuous improvements are planned and implemented on an ongoing basis.
  • Manage a team of Quality Engineers and Technicians. Coach and mentor the team.

Qualifications

  • Degree / Diploma qualification in Engineering, Science and/or Quality or relevant experience in a quality assurance role within the Medical Device Industry. 
  • A minimum of 7 years’ experience in a similar role.
  • Proven track record in leading quality within a medical device manufacturing company.
  • Ability to manage quality related projects.
  • Proven track record in people management. Must be able to manage a team of up to 8 staff.
  • Excellent attention to detail.
  • Thorough knowledge of applicable regulatory requirements (ISO 13485, FDA etc.)
  • Proven track record in problem solving. 6 sigma qualification (Green Belt of higher).
  • Understanding of lean principles. Lean green belt an advantage.
  • Excellent communication skills both verbal and written. 
  • A positive attitude in dealing with people.
  • Ability to learn and adapt to various situations.
  • Must be able to work under own initiative, with minimum supervision.

For more information or a confidential discussion about this role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706 717