Essential Functions
- Senior Quality leader role to shape the strategy and create the operating
structure for the global quality system within P&Ls of Clinical
Systems
- Develop an team of quality of professionals who work in partnership
with the business/P&L’s functional teams to drive wing to wing product
quality through critical metrics trend analysis and implementation of
improvement initiatives for the total product life cycle.
- Provide effective guidance and oversite for general processes, as
well as own key decisions in all areas of product risk management and
mitigation execution.
- Ensure compliance to existing US, EU, Canadian and Asian quality system
requirements and translate new industry trends and requirements into
business policy and practice
Qualifications/Requirements:
- Working knowledge of global regulatory requirements for medical devices
including US, Canadian, European and Asian regulations
- Minimum ten years experience with increasing responsibilities in medical
device quality systems across the complete product life cycle.
- Familiarity of standards applicable to Clinical systems product lines
- Demonstrated ability to lead and develop people in a large, virtual,
global and matrixed environment
- Effective influence and consensus building across diverse teams of
individuals at all levels of organization
- Executive presence and communication skills
- Strong, credible reputation within the quality and regulatory profession
as well as with business leaders being supported.
- Bachelor degree in Science, Engineering or Business.
Desired
- Lead auditor certification
- Six Sigma Black Belt certified
- Experienced in a healthcare clinical environment
- Front line experience in manufacturing, R&D, sourcing, organization
change management
- Strong medical device regulatory background
- Experience in building a Quality management system from ground up.
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