Job Overview:
We are seeking a Quality Assurance Specialist to join our expanding team. As part of the Design Quality Assurance team, you will be responsible for demonstrating commitment to quality policies 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. The successful candidate will lead projects related to drug-coated balloon product lines and will have supervision responsibility within their reporting structure, providing coaching and mentoring support.
Key Responsibilities:
* Understand requirements and procedures that govern medical device Design Control.
* Ensure project deliverables comply with all internal and regulatory requirements.
* Provide design quality leadership in resolving PIRs, CAPAs, NCEPs, and regulatory requirement changes.
* Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams to provide technical and quality systems input.
* Lead design change projects, including scoping, assessment, and implementation.
* Update documents within the Risk Management File, such as Hazard Analysis, Task and Use Error Analysis, and Design FMEA.
* Maintain regulatory compliance with company SOP/WIs and EU/FDA/Global guidelines.
* Apply sound problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* Support internal and external regulatory audits.
* Contribute to post-market surveillance activities, such as Field Signal Evaluations and Q&A from regulatory authorities.
Requirements:
* NFQ Level 8 qualification in a STEM discipline.
* Min 6 years experience in industry; Design Assurance experience would be preferable.
* Experience in areas such as design control, risk management, design change, and standards compliance.
* Strong leadership, problem-solving, technical capabilities, communication, and collaboration skills.
* Ability to work well both as part of a team and individually.
* Enthusiasm and motivation to develop career, drive improvements in product and process quality, and coach and develop team members.
About Us:
We are a leading medical science organization committed to advancing science for life, transforming lives through innovative medical solutions that improve patient lives, create value for customers, and support employees and communities.