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Director of Quality and Compliance
hace 2 semanas
About the Position
We have an excellent opportunity for a Senior Director, Quality Engineering to join our quality organization at Edwards Lifesciences. As a key member of our team, you will play a critical role in ensuring the highest standards of integrity and safety in our innovation process.
As a Senior Director, Quality Engineering, you will lead a team of quality engineers who are responsible for various activities such as process and test methods validations, product transfer, process improvements, non-conformance investigation, corrective action, product disposition, complaint analysis, and risk management. You will also develop quality processes, staffing, planning, budgeting, align priorities, performance management, and work through managers to achieve results.
Main Responsibilities
- Lead a team of quality engineers responsible for various activities such as process and test methods validations, product transfer, process improvements, non-conformance investigation, corrective action, product disposition, complaint analysis, and risk management.
- Develop quality processes, staffing, planning, budgeting, align priorities, performance management, and work through managers to achieve results.
- Drive a culture that is focused on quality and business results.
- Create an environment that fosters employee motivation and engagement.
- Plan, prioritize, and direct strategic program activities including product, process, and quality projects using engineering methods such as Six Sigma and LEAN methods to align with applicable compliance standards.
- Collaborate with leadership to develop operational strategy.
- Partner with cross-functional groups/resources to achieve tactical execution of business objectives.
Essential Qualifications
- Bachelor's Degree related field with experience in engineering and skill levels exceeding the requirements of the Director, experience in quality engineering, quality management, and regulatory compliance within the medical device industry.
- Proven successful project management leadership skills.
- Proven expertise in both Microsoft Office Suite and related systems.
- Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.
- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
- Expert understanding of engineering procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems.
- Expert understanding of related aspects of quality engineering processes and/or systems.
- Expert knowledge of domestic and international regulatory requirements such as FDA, GMPs, and ISO/EN standards.
- Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing.
- Knowledge of financial acumen as it relates to the business as well as quality engineering.
- Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.
- Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality engineering to the business.
