Senior Quality Manager for Medical Devices
hace 1 semana
About the Job
We have an exciting 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 shaping the development of groundbreaking technologies and 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.
Responsibilities
- Team Leadership: 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.
- Process Development: Develop quality processes, staffing, planning, budgeting, align priorities, performance management, and work through managers to achieve results.
- Culture Management: Drive a culture that is focused on quality and business results.
- Employee Engagement: Create an environment that fosters employee motivation and engagement.
- Strategic Planning: 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.
- Operational Strategy: Collaborate with leadership to develop operational strategy.
- Cross-Functional Collaboration: Partner with cross-functional groups/resources to achieve tactical execution of business objectives.
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.
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