Senior Quality Assurance Specialist

1 week ago

Enniscorthy, Loch Garman, Ireland beBeeRiskManagement Full time €72,000 - €96,000

Job Title: Senior Quality Assurance Specialist

About the Role

This position is responsible for ensuring quality and risk management throughout the lifecycle of new product development projects. The successful candidate will represent quality interests within project teams, lead quality engineering tasks, and manage risk activities.

Main Responsibilities
  • Represent quality concerns on project teams to ensure adherence to regulatory requirements.
  • Lead risk management activities for NPD projects by identifying, assessing, and mitigating risks.
  • Balancing multiple projects and tasks from inception to launch and maintenance requires strong organizational and time-management skills.
  • Review design control compliance requirements for NPD projects to ensure they meet regulatory standards.
  • Develop UFMEA & DFMEA, coordinate guidance from design sub-team members to ensure quality and efficiency.
  • Perform DOE's and statistical analysis to support product and process optimization, driving business growth and customer satisfaction.
  • Support biocompatibility testing as per ISO10993 and company procedures to ensure product safety and efficacy.
  • Participate in internal audit and supplier audit programs to maintain quality standards and drive continuous improvement.
  • Risk management involves U/DFMEA, Risk Analysis, Risk Management File, Gauge R&R, and Test Method Validation to ensure product quality and reliability.
Requirements
  • Third-level Engineer / Technical / Science Qualification with a strong background in quality assurance.
  • Minimum 5 years in the medical device or pharmaceutical industry, with experience in quality assurance and risk management.
  • Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971, and CMDR to ensure compliance and regulatory excellence.
  • Excellent problem-solving techniques, adaptability, attention to detail, and excellent interpersonal skills are essential for this role.

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