Senior Quality Assurance Expert

1 week ago

Galway, Galway, Ireland beBeeQualityAssurance Full time €95,000 - €105,000

We are seeking a highly skilled Senior Quality Assurance Engineer to join our team. As part of the Design Quality Assurance team, you will play a key role in demonstrating commitment to the Quality Policy by executing sound quality practices and maintaining an effective quality system.

The Design Quality Assurance team supports a wide product portfolio including drug eluting therapies, balloon dilatation catheters and cutting balloons for Interventional Cardiology. You will lead projects related to the drug-coated balloon product line and have supervision responsibility within your reporting structure - providing coaching and mentoring support to team members.

You will lead projects to support quality, compliance, material continuity, and design Value Improvement Projects (VIPs), ensuring that all design changes are compliant with associated regulations and procedures.

Key Responsibilities:

  • In-depth understanding of requirements and procedures that govern medical device Design Control.
  • In-depth understanding of Design Assurance requirements to ensure project deliverables comply with all internal and regulatory requirements.
  • Provide design quality leadership in the resolution of PIRs, CAPAs, NCEPs, and regulatory requirement changes.
  • Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations team environments to provide technical and quality systems input.
  • Draws conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities.
  • Lead design change projects including scoping, assessment and implementation, through a combination of individual contribution and providing direction to team members.
  • Lead updates to documents within the Risk Management File, such as the Hazard Analysis, Task and Use Error Analysis and Design FMEA.
  • Ensure and maintain regulatory compliance with appropriate guidance documents such as company SOP/WI's and EU/FDA/Global guidelines.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Support internal and external regulatory audits as required.
  • Provide support and direction for post market surveillance activities, such as Field Signal Evaluations, assessment of field product performance, NCEPs, Periodic Safety Update Reports (PSURs) and Q&A from regulatory authorities.
  • Provide coaching and development support within their reporting structure, including assignment and oversight of small to medium projects within the sustaining organization.

Education & Experience:

  • NFQ Level 8 qualification in a STEM discipline.
  • Min 6 years experience industry experience; Design Assurance experience would be preferable.
  • Experience in areas such as design control, risk management, design change, and standards compliance (to regulatory requirements).
  • Strong leadership, problem-solving, technical capabilities, communication and collaboration skills.
  • Proven ability to work well both as part of a team and individually.
  • Is enthusiastic and fully motivated to develop their career, to demonstrate best practices in line with the department and site objectives and continually seeks to drive improvements in product and process quality.
  • Interested in coaching and developing team members.

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