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Senior Quality Assurance Engineer

2 weeks ago

Ballina, Mayo County, Ireland beBeeQuality Full time €60,000 - €90,000

Key Responsibilities:

  • Investigate customer complaints to identify root causes and ensure timely resolution in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations.
  • Develop and implement corrective actions to mitigate identified risks and prevent recurrence of quality issues.
  • Collect and analyze data related to product performance, complaints, non-conformances, and process deviations; present findings in a clear and actionable manner.
  • Author high-quality technical documentation, including investigation reports, records, risk assessments, and trend analyses.
  • Collaborate closely with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, and Customer Service) to drive resolution of quality issues and ensure compliance with internal and external standards.
  • Support audits by preparing documentation, participating in audit activities, and following up on audit findings.
  • Participate in initiatives to enhance quality systems, processes, and product reliability.

Qualifications:

Required:

  • Bachelor's degree in Engineering or Life Sciences.
  • 5-8 years quality assurance or compliance in the medical device or a similarly regulated industry.
  • Solid understanding of FDA QSR, ISO 13485, and relevant international regulations.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Proficient in data analysis tools.

Preferred:

  • Experience with surveillance and complaint handling processes.
  • Knowledge of EU MDR and international medical device regulations.
  • Strong attention to detail and commitment to quality.
  • Collaborative mindset with ability to work effectively across departments.
  • Self-motivated with a continuous improvement mindset.

EOE Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.