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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Staff Quality Engineer


Reference:JCA00527 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Senior Quality Engineer

Our client a global medical device company currently seek a Staff Quality Engineer to join their team. Reporting to Quality Manager The Staff Quality Engineer will be accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.The Staff Quality Engineer will be responsible for providing quality leadership, guidance, and support for new product development and sustaining engineering projects. Candidate will work with other functions within the organization, such as R&D, Regulatory, Medical, Operations, and Marketing, to ensure regulatory compliance, satisfy business needs, and improve processes. This position requires the ability to handle multiple projects and tasks utilizing a high level of written and oral communication skills.


In this position, the incumbent may participate or lead in the following:





Role/Responsibilities

  • Design, Development and Quality Planning
  • Development of Technical Requirements and Product Specifications
  • Risk Management / FMEA
  • Design Verification and Design Validation
  • Test Method Development and Validations
  • Statistical Analysis
  • Quality Functional Deployment (QFD)
  • Process Development and Validation
  • Sampling Plan Development
  • Manufacturing Quality Plan Activities
  • Design Reviews
  • Design Transfer Activities
  • Design History File Management
  • Reliability Testing
  • Change Management



Skills/Experience:
  • BS degree in engineering or technical sciences. MS preferred.
  • A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience.
  • Excellent knowledge of design controls and 21CFR820, ISO 13485, ISO 14971, ISO 10993 and applicable medical device regulations.
  • Class II medical device experience required.
  • Proficiency in risk analysis techniques (e.g. fault tree, FMEA) and experience leading others through process mapping exercises and coaching others in problem solving.
  • Demonstrated ability to make critical decisions regarding product quality or quality system compliance. Ability to assess and articulate risk when evaluating a situation.
  • Design for Six Sigma training and certification is desired along with knowledge of statistical methodologies.
  • Professional certifications (CQE, CQA, CRE) are desirable.
  • In vitro diagnostic (IVD) experience is strongly preferred.
  • Excellent communication, problem solving, organizational and interpersonal skills are required.
  • Strong project management skills required.
  • Experience with software quality assurance principles preferred.


For further information please contact James Cassidy [email protected] or call in confidence 0860204322