Senior Quality Assurance Specialist

5 days ago

Enniscorthy, Loch Garman, Ireland beBeeQualityEngineer Full time €80,000 - €100,000

About this job

Job Overview

This role is responsible for ensuring quality and risk management throughout the lifecycle of new product development projects.

The individual represents quality interests within project teams, leading quality engineering tasks and risk management activities such as UFMEA, DFMEA, PFMEA, and related documentation.

They are accountable for reviewing design compliance, conducting statistical analyses (e.g., DOE), and initiating corrective actions when necessary.

The role also involves supporting biocompatibility testing aligned with ISO10993, participating in internal and supplier audits, and validating test methods and measurement systems like Gauge R&R.

Candidates should possess a third-level qualification in engineering, science, or a technical field, along with a minimum of five years of experience in the medical device or pharmaceutical industries.

A solid understanding of regulatory standards, including ISO 13485, ISO 14971, and related CFRs, is essential.

Preferred skills include attention to detail, adaptability, strong problem-solving abilities, and excellent interpersonal skills.

  • Represent quality interests and concerns on project teams.
  • Lead risk management activities and own the Quality engineering activities for NPD projects.
  • Balance multiple projects and tasks from product inception through product launch and maintenance.
  • Review design control compliance requirements for NPD projects and all design elements.
  • Develop UFMEA & DFMEA, coordinating guidance from other design sub-team members and supporting PFMEA development.
  • Perform DOE's and other statistical analysis to support product and process optimisation or resolve causes of process variation.
  • Initiate corrective actions as required.
  • Support assessment of Biocompatibility testing required as per ISO10993 and company procedures.
  • Participate in internal audit and supplier audit programmes.
  • Risk management – U/DFMEA; Risk Analysis, Risk Management File and Gauge R&R and Test Method Validation.

About you

  • Third-level Engineer / Technical / Science Qualification
  • Minimum of 5 years in the medical device or pharmaceutical industry is desirable
  • Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR.
  • Attention to detail and adaptability
  • Dedication to excellence, flexibility
  • Problem-solving techniques with excellent organisation skills
  • Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to target and deadlines

This is an exciting opportunity

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