Senior Quality Assurance Professional

6 days ago

Galway, Galway, Ireland beBeeQuality Full time €65,000 - €85,000

Job Title:

  • Serving as the principal Quality Assurance representative to ensure alignment with corporate goals and objectives.

Responsibilities:

  • Maintain a comprehensive quality management system, reporting performance metrics to senior leadership.
  • Lead a team of Quality Technicians and Engineers in achieving departmental objectives.
  • Oversight of quality assurance activities, including audits, review programs, and corrective action implementation.
  • Ensure effective supplier control, including vendor evaluation, audit schedules, and quality agreements.
  • Promote manufacturing validation processes, developing MVPs, PFMEAs, and validation protocols.
  • Analyze customer complaints, approve reports, and identify trends for process improvements.
  • Investigate and resolve CAPA and NCR issues in a timely manner.
  • Manage lot release procedures, including routine sterilization and product clearance.
  • Co-lead external audits, ensuring compliance with FDA and regulatory requirements.
  • Support Operations teams to achieve quality, cost, and output targets.

Qualifications & Experience:

  • Bachelor's degree in a scientific field required; 4 years' experience in medical device or pharmaceutical industry.
  • Demonstrated knowledge of ISO and CFR guidelines.
  • Ability to work collaboratively, meeting deadlines and goals efficiently.
  • Proven organizational, management, and communication skills.
  • Strong interpersonal and communication skills essential.
  • Deep understanding of quality principles and ability to apply them in development and manufacturing environments.

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