Senior Quality Assurance Engineer

2 weeks ago

Galway, Galway, Ireland beBeeDesignAssurance Full time €70,000 - €80,000

About your new role in Design Assurance:

We are seeking a skilled professional to lead projects within the balloon catheter product family and supervise a team of engineers.

This role involves ensuring all design changes meet regulatory and procedural requirements, including post-market surveillance, quality, compliance, material continuity, and value improvement projects.

  • Regulatory Compliance
  • Design Assurance
  • Project Management
  • Team Supervision
Key Responsibilities:
  1. A strong understanding of medical device Design Control requirements and procedures.
  2. Expertise in Design Assurance to ensure projects comply with internal standards and regulatory requirements.
  3. Lead the resolution of issues related to PIRs, CAPAs, NCEPs, and regulatory changes.
  4. Collaborate with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations to provide technical and quality guidance.
  5. Interpret test data and make decisions using excellent analytical and problem-solving skills.
  6. Manage design change projects from scoping and assessment to implementation, guiding team members as needed.
  7. Maintain and update Risk Management File documentation, including Hazard Analysis, Task and Use Error Analysis, and Design FMEA.
  8. Ensure ongoing regulatory compliance with SOPs/WIs and EU/FDA/global guidelines.
  9. Apply structured problem-solving methods to identify, prioritize, and resolve quality issues.
  10. Support internal and external regulatory audits as required.
  11. Oversee post-market surveillance activities, including field product assessments, NCEPs, PSURs, and regulatory queries.
  12. Provide coaching and mentoring to team members, including oversight of small to medium projects.

What skill/experience you need for this role:

  • NFQ Level 8 qualification in a STEM field.
  • At least 6 years industry experience, ideally including Design Assurance.
  • Skilled in design control, risk management, design changes, and regulatory compliance.
  • Strong leadership, problem-solving, technical communication, and teamwork abilities.
  • Able to work autonomously and collaboratively.
  • Driven to advance their career, promote best practices, and continuously improve product and process quality.
  • Committed to mentoring and developing team members.

Why choose us?

We offer a competitive salary package and opportunities for professional growth and development.

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