Senior Quality Assurance Engineer

5 days ago

Shannon, Ireland Aerogen Full time

About Aerogen

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Aerogen is a global leader in acute care aerosol drug delivery, headquartered in Galway, Ireland. Our company has received multiple MedTech awards and has been recognized for Respiratory Care Excellence in North America eight times.

We have a talented team that collaborates to innovate, challenge, and test not only our products but every aspect of how we work. Our goal is to deliver better patient care through innovative solutions to complex problems.

Our business is growing rapidly across the globe, and our core culture of 'We Care' connects us universally. We believe that your ambition and integrity fuel ours, and we are committed to supporting our employees to reach their full potential through tangible investment in their careers.

The Role

The Senior Quality Engineer (Projects), reporting to the Senior Quality Manager, is a key member of the Manufacturing Quality group. This role is responsible for maintaining high-quality standards in their area, driving quality engineering activities for manufacturing processes, materials, and products, and leading relevant resources as part of a team.

Key Responsibilities

  1. Demonstrate strong leadership and a clear identifiable work ethos within the Quality Engineering Team.
  2. Lead Quality Engineering support to Aerogen's development process, driving process continuous improvements and providing manufacturing support. This includes:
  3. Process/manufacturing data analysis, trending, and assisting yield reporting.
  4. Investigation root cause analysis of quality issues in manufacturing and managing quality-related NC's and CAPA's.
  5. Establish analysis techniques and other quality control tools such as SPC, Cpk, Ppk.
  6. Address ongoing compliance.
  7. Establish inspection plans, frequencies, and test methods for incoming material/parts.
  8. Appropriately train, develop, and manage resources within the Quality Engineering support team to ensure objectives are communicated and delivered within agreed requirements.
  9. Supporting Quality Management in the development of key objectives and strategies to ensure continuous growth of personnel and quality systems improvements.
  10. Overall responsibility for GMP standards and compliance within Aerogen's manufacturing area.
  11. Drive risk management activities in manufacturing (Process FMECA).
  12. Manage process quality control system to ensure all manufactured product meets defined specifications prior to shipment.
  13. Maintain compliance with ISO and FDA Quality System regulations.
  14. Perform other assigned tasks and support all aspects of the Quality System as directed by the Manager.
  15. Manage both Product and Process Verification and Validation activities as related to the specific scope of planned work associated with the asset/process in question.
  16. Provide statistical overview of all relevant activities to ensure that use of sampling plans and treatment of results adheres to best-accepted statistical practice.

What Education and Experience Are Required?

  1. BE/BS Degree. A post-graduate qualification in Quality Assurance is preferable although not mandatory.
  2. At least eight years Quality Engineering experience or related role within the medical device or Pharma sectors.
  3. Minimum certification to Green Belt Lean Six Sigma (or recognized equivalent qualification).

What Key Skills Will Make You Great at the Role?

  1. Ability to work on own initiative.
  2. Strong team member with the ability to identify and drive implementation of innovative quality improvements.
  3. Ability to consistently meet deadlines.
  4. Demonstrate and actively promote high levels of professional quality engineering.
  5. Good communication skills. Must have the ability to communicate effectively at all levels of the company.
  6. Ability to write clear, concise technical protocols and reports.
  7. Good administrative/organizational ability with high level of attention to detail.
  8. Ability to liaise with suppliers, customers, and regulatory contacts in an informed professional manner.
  9. Thorough understanding of ISO 13485, FDA, QSR MDR 2017/745.

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