Design Assurance Quality Lead

2 weeks ago

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

**Job Title:** Design Quality Assurance Supervisor

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About the Job:
This is an exciting opportunity to join our organization as a Design Quality Assurance Supervisor. In this role, you will be responsible for leading projects within the balloon catheter product family and supervising a team of at least three engineers.

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Key Responsibilities:
• Lead the resolution of PIRs, CAPAs, NCEPs, and regulatory changes with design quality oversight.
• Collaborate with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations to provide technical and quality guidance.
• Interpret test data and make decisions using excellent analytical and problem-solving skills.
• Manage design change projects, from scoping and assessment to implementation, guiding team members as needed.
• Maintain and update Risk Management File documentation, including Hazard Analysis, Task and Use Error Analysis, and Design FMEA.
• Ensure ongoing regulatory compliance with SOPs/WIs and EU/FDA/global guidelines.
• Apply structured problem-solving methods to identify, prioritize, and resolve quality issues.
• Support internal and external regulatory audits as required.
• Oversee post-market surveillance activities, including field product assessments, NCEPs, PSURs, and regulatory queries.
• Provide coaching and mentoring to team members, including oversight of small to medium projects.

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Required Skills and Qualifications:
• 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.

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What We Offer:
• A competitive salary package
• Great benefits package
• Opportunities for career advancement and professional growth

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How to Apply:
Apply now by clicking "Apply Now" or get in touch if the job isn't quite right but you are looking for something similar.

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