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Senior Quality Manager

3 weeks ago

Shannon, Ireland Aerogen Ltd Full time

About Aerogen Ltd:
A world leader in acute care aerosol drug delivery, headquartered in Galway, Ireland. Our team collaborates to innovate and find solutions to complex problems, delivering better patient care.

Job Description:

Key Responsibilities
  • Demonstrate leadership and a clear work ethos within the Quality Engineering Team.
  • Drive quality engineering activities for manufacturing processes, materials, and products, leading relevant resources as part of a team.
Responsibilities
  • Process/manufacturing data analysis, trending, and yield reporting.
  • Investigation root cause analysis of quality issues in manufacturing and managing NC's and CAPA's.
  • Establish analysis techniques and quality control tools such as SPC, Cpk, Ppk.
  • Address ongoing compliance.
  • Establish inspection plans, frequencies, and test methods for incoming material/parts.
  • Train, develop, and manage resources within the Quality Engineering support team.
  • Support Quality Management in developing key objectives and strategies.
  • Ensure GMP standards and compliance within Aerogen's manufacturing area.
  • Drive risk management activities in manufacturing (Process FMECA).
  • Manage process quality control system to ensure manufactured product meets defined specifications prior to shipment.
  • Maintain compliance with ISO and FDA Quality System regulations.
Requirements
  • BE/BS Degree, post-graduate qualification in Quality Assurance preferable.
  • At least eight years Quality Engineering experience or related role within medical device or Pharma sectors.
  • Minimum certification to Green Belt Lean Six Sigma.