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Senior Quality Assurance Engineer

Job description

Senior Quality Assurance Engineer

The successful candidate will work as part of a team to maintain high quality/performance standards across the company.

Responsibilities:

  • Collaborate with the Project teams to facilitate the successful execution of the Design Services process and Commercialization of new products
  • Provide expertise in the areas of Quality Assurance, Design Controls, Risk Management, Statistical Techniques, and Regulatory Compliance and Submissions
  • Ensure that new medical device product development / new product introduction and changes to existing products are conducted in compliance with global regulations and internal procedures
  • Participate in change review process for existing medical device products and new products under development
  • Review Design History Files and Technical Files for conformance to applicable requirements
  • Contribute to process improvement efforts by developing and updating procedures and work instructions
  • Develop and maintain documentation in compliance with FDA, ISO, MDD/MDR requirements Provide on-going support to manufacturing site(s) for commercially available products
  • Process Customer Complaints and manage customer replies
  • Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations
  • Initiate / Support implementation of effective Corrective / Preventive Actions

 

Experience:

  • Degree in manufacturing engineering quality engineering, life science or related field
  • Minimum of 5 years’ experience within the Medical Device industry at a senior level
  • Proven record of handling multiple tasks simultaneously and ability to manage project timelines
  • Can demonstrate understanding and application of quality philosophies, principles, systems, methods, tools and standards
  • Must be highly motivated with excellent communication skills and proven ability to work effectively as part of a team and interact professional with all organizational levels
  • Act as a mentor to less experienced colleagues
  • Quality certification and lead auditor certification is a plus
  • Suppler quality engineering is a plus
  • Sterilization / Microbiology experience is a plus

  

To apply for this position please contact Keeva O’Shea at Sigmar Recruitment T: +353 91 749264 E:   koshea@sigmar.ie

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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