Senior Quality Engineer

3 weeks ago

Galway, Ireland Pale Blue Dot® Recruitment Full time

Our Client, a leading Medtech company in Galway are seeking a Senior Quality Engineer NPI/Design Assurance to join their team. The Senior Quality Engineer will provide quality engineering support and leadership to our NPI and Operations Teams. Reporting to the Quality Manager, the position will be challenging and will require an ability to both lead a team and work on one’s own initiative with a minimum of supervision. The role will take the lead in implementing and improving quality engineering throughout the business.


Responsibilities include but are not limited to:

  • Lead and effectively deliver all quality related aspects of New Product Introduction, ensuring all customer requirements are identified, documented, understood and met.
  • Be part of project teams. Deliver on commits to schedule and budget.
  • Work with customers and suppliers on quality related issues and new product introduction projects. Ensure all dealings are professional and good relationships are always maintained.
  • Ensure processes are validated in accordance with customer and Freudenberg Medical's Quality System requirements. Write validation protocols, reports and test reports as required.
  • Ensure that all customer requirements are identified, clearly documented in Freudenberg Medical's manufacturing documentation and effectively implemented.
  • Assess all product and manufacturing related changes, deviations and reworks, for their impact on validations, product quality and customer requirements.
  • Lead and investigate product/process quality issues that arise, including customer complaints. Ensure they are effectively resolved in a timely manner using the Freudenberg Medical's CAPA system.
  • Ensure the Quality System is fully compliant with customer and regulatory requirements.
  • Lead the implementation of Structured Problem Solving to drive root cause identification for process and product issues.
  • Drive and implement continuous improvement to processes and product quality.
  • Perform an active role in further development of the quality management system.
  • Supervision, coaching and mentoring of Quality Technicians and Quality Engineers.
  • Work with suppliers and customers on the resolution of product quality issues and quality improvement programs.
  • To take on other duties which the Company may assign you from time to time.
  • Keep your skills current and be conversant with the latest developments which are relevant to the Company’s business.
  • Bachelor’s degree in Science, Engineering, Manufacturing or related field.
  • Thorough knowledge of medical devices quality systems (ISO13485/FDA).
  • A minimum of five years of relevant progressive experience within a similar environment role.
  • Experience of New Product Introduction and manufacturing process transfer.
  • Strong Structured Problem Solving and Root Cause Analysis experience (Lean 6 Sigma Green Belt desirable).
  • Strong leadership and people management skills.
  • Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.).
  • Must be able to communicate at all levels of the organization and with customers, suppliers and regulatory agencies.
  • Good interpersonal skills, team player, with a positive attitude in dealing with people.
  • Must be innovative and be driven to implement change to systems and procedures.
  • Excellent analytical skills. Ability to define problems, collect data, establish facts, and draw conclusions.
  • Demonstrable ability to achieve goals through collaborating, influencing and interaction at all levels across the business/function.

Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies


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