Quality & Design Specialist (NPD)

Competitive
Permanent
Dublin North
26 May 2020
BBBH760197

Do you have strong electro-mechanical skills and quality control understanding?

PERM | DUBLIN NORTH | VERY COMPETITIVE SALARY & GREAT BENEFITS

This a priority role, with interviews taking place virtually over the next two weeks

THE ROLE
I am delighted to be partnering with a well established medical device company based in Dublin who are looking to attract a driven and ambitious NPD Quality Specialist Professional to join their expanding team, who will specialise in quality controls across NPD and NPI on site. so this is an exciting time to join this company. The ideal candidate for this role will have strong demonstrated electro-mechanical understanding, alongside medical device regulatory and quality control understanding. The successful candidate will be responsible to provide direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for NPD, TMDs, and Design Changes on products. They will lead Quality Management System improvement projects internally. This team views the incorporation of Quality Control as collaboration on-site, therefore the successful candidate will have great cross-functional communication experience.

THE RESPONSIBILITIES

  • Acts as Subject Matter Expert (SME) for application of Design Controls, while supporting development and design change teams in accordance with regulatory expectations and company procedures, providing competent Supplier Quality audit support with respect to the implementation of all Design Controls elements
  • Incorporate quality engineering principles and problem-solving skills (risk analysis, problem-solving methodologies, statistical techniques, etc.) to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
  • Provides guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations related to Design Controls, Risk Management, Quality Engineering
  • Ensures the comprehensive completion of risk management, Design Verification, Process Validation, and Design Validation activities for products and processes
  • Support the development and validation of appropriate test methods for product and process performance

THE REQUIREMENTS

  • Level 8 Engineering Degree, preferably in mechanical, electro-mechanical, mechatronics or related field
  • 5 + years relevant experience in a regulated environment
  • A core understanding of FDA regulations and medical device quality control is needed
  • A self-starter, excited by the challenge of complex products and technology, with a strong problem-solving ability
  • Strong leadership skills and ability to influence cross functional teams to drive work from scope to completion

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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