Senior Quality Assurance Engineer

4 days ago


Dublin, Dublin City, Ireland Mason Alexander Full time

Direct message the job poster from Mason Alexander

We are delighted to be partnering with an exciting Medical Device company based in Dublin, on a permanent Senior Quality Engineer position.

This role will be a significant contribution to this company in a pivotal stage of their growth and will focus on driving the day to day implementation of the QMS with a focus on continuous improvement. You will support manufacturing, supply chain and design assurance activities and represent the quality function cross functionally.

As Senior Quality Engineer, your responsibilities will include:

  • Drive the day to day implementation of the QMS
  • Ensure delivery of overall quality strategy & support achievement of the business quality objectives
  • Collaborate with wider team to ensure necessary QA activities are planned, executed and documented
  • Develop and review test specifications, part specifications & design specifications with cross functional team
  • Support manufacturing team activities associated with manufacturing in a regulated environment e.g. equipment qualification, process validation and change control
  • Provide practical QA and Design Assurance expertise
  • Support supply chain in supplier related activities e.g. process development and manufacturing requirements
  • Coordinate and manage key activities such as internal audit programme, material review board, NC/CAPA review board, complaint process
  • Project support for regulatory submissions
  • Support clinical investigations

Education & Experience Required:

  • Bachelor's Degree in Engineering, Science or related field
  • 5+ years' experience in medical device quality/design assurance role
  • Recent regulatory experience including FDA regulations, ISO 13485, Medical Device Directive and other applicable national and international regulations and standards

This role is based on-site in Dublin, current working arrangements are 4 days onsite and 1 day from home per week.

This is a fantastic opportunity to join a hugely successful company at an exciting time in their development and significantly contribute to their growth

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance, Manufacturing, and Science

Industries

Medical Equipment Manufacturing, Hospitals and Health Care, and Pharmaceutical Manufacturing

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