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Senior Supervisor Design Quality Assurance, Galway
Location: Galway, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 19e0ded414aa
Job Views: 8
Posted: 10.08.2025
Expiry Date: 24.09.2025
Job Description:
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we offer opportunities to work in diverse, high-performing teams tackling important healthcare challenges. We provide access to the latest tools, information, and training to support your career growth.
Position: Senior Design Quality Assurance Manager (Permanent)
Purpose: To demonstrate commitment to the Quality Policy by executing sound quality practices and maintaining an effective quality system within the Design Quality Assurance team. The role supports a product portfolio including drug eluting therapies, balloon dilatation catheters, and cutting balloons for Interventional Cardiology.
The successful candidate will lead projects related to the balloon catheter product family, supervise at least 3 engineers, and oversee small to medium projects within the sustaining organization.
Responsibilities include supporting post-market surveillance, quality, compliance, material continuity, and design VIPs, ensuring all design changes comply with regulations.
Key Responsibilities:
* Understand requirements governing medical device Design Control.
* Ensure project deliverables comply with internal and regulatory requirements.
* Lead resolution of PIRs, CAPAs, NCEPs, and regulatory changes.
* Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams.
* Analyze test data to draw conclusions and make decisions.
* Lead design change projects, including scoping, assessment, and implementation.
* Update documents within the Risk Management File.
* Maintain regulatory compliance with guidance documents and standards.
* Apply systematic problem-solving methodologies.
* Support regulatory audits.
* Support post-market surveillance activities.
* Provide coaching and development support within the team.
Education & Experience:
* Minimum 6 years’ industry experience; Design Assurance experience preferred.
* Experience in design control, risk management, design change, and standards compliance.
* Strong leadership, problem-solving, communication, and collaboration skills.
* Ability to work independently and in teams.
* Motivated to develop career and drive quality improvements.
* Interest in coaching and developing team members.
Boston Scientific is committed to providing reasonable accommodations for applicants and employees with disabilities. Please contact us if needed.
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