Design Quality Assurance Senior Supervisor
Job Description:
We are seeking a highly skilled and experienced individual to fill the role of Design Quality Assurance Senior Supervisor. This position will be responsible for leading projects related to balloon catheter product family, including balloon dilatation catheters, cutting balloons, and micro-catheters. The successful candidate will have supervision responsibility within their reporting structure for a minimum of 3 engineers and provide coaching and mentoring support.
The Design Quality Assurance team supports a wide product portfolio, including drug eluting therapies, balloon dilatation catheters, and cutting balloons for Interventional Cardiology. As part of this team, the Design Quality Assurance Senior Supervisor will be responsible for demonstrating commitment to the Quality Policy by executing sound quality practices and maintaining an effective quality system.
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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.
* Lead design change projects, including scoping, assessment, and implementation, through a combination of individual contribution and providing direction to team members.
* Ensure and maintain regulatory compliance with appropriate guidance documents.
* Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
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Requirements:
To be considered for this role, you will need to have a minimum of 6 years' industry experience, with experience in areas such as design control, risk management, design change, and standards compliance. Strong leadership, problem-solving, technical capabilities, communication, and collaboration skills are also essential.
You should be able to work well both as part of a team and individually and be enthusiastic about developing your career. You should also be interested in coaching and developing team members.
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About Us:
We are a global business committed to advancing science for life. We recognize that nurturing a diverse and inclusive workplace helps us be more innovative and is essential in advancing science for life and improving patient health.
We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.