Senior Quality Specialist

2 weeks ago

Cork, Cork, Ireland beBeeQuality Full time €60,000 - €80,000

Job Title: Quality Assurance Associate

Key Responsibilities:
  • Maintain the effectiveness of our quality management system, ensuring continuous improvement and adherence to regulatory standards.
  • Oversee daily QA activities, including vendor management, internal audits, and product compliance enhancements.
  • Support notified body audits and internal assessments, maintaining accurate records and documentation.
  • Coordinate quality system schedules, including supplier audits, management reviews, and documentation updates.
  • Collaborate with the wider team to ensure product manufacturing and testing meet required specifications.
  • Foster strong relationships with suppliers, monitoring performance, and conducting audits to ensure quality standards are met.
  • Analyse and resolve product quality issues, implementing corrective and preventive actions to prevent recurrence.
Requirements:
  • Bachelor's degree in engineering or science; ISO 13485 certification is mandatory.
  • A minimum of 4 years' experience in medical device QA within a regulated industry.
  • In-depth knowledge of ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 820 regulations.
  • Desirable lead auditor certification and/or Regulatory certifications.
  • Demonstrated ability to manage projects to deadlines, with excellent problem-solving and communication skills.
  • Experience with Good Documentation Practice and report writing.
  • Project management experience, with a strong ability to collaborate with interdisciplinary teams.

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