CrossRoads is recruiting for a Quality Manager , located in Memphis, TN office.
DePuy Synthes , part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.
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We are looking for someone to lead the quality engineering group to implement engineering and quality systems, and regulatory compliance strategies and objectives. As the Quality Manager you will define, lead, and implement state-of-the-art quality engineering focus and improvements in design and development of products, and in transfer and steady state phases of manufacturing operations.
- Implements the continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes.
- Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business.
- Conducts effective technical design reviews and effectively implements and utilizes quality tools within research and development and new product development.
- Submits research on worldwide regulatory and technical standards environments for shift in design related quality trends.
- Develops and manages leading engineers to create effective quality engineering processes at all levels and throughout the engineering organization.
- Ensures oversight of engineers in development and deployment of innovative quality engineering tools, techniques and systems that will drive product development to successfully achieve key business goals.
- Ensures the implementation of premier quality engineering systems to support entire product life cycle with focus on business results including prevention and detection of defects at earliest phases.
Position duties & responsibilities:
- Lead the New Product Development (NPD) and Quality Engineers supporting CrossRoads Extremity Systems Foot and Ankle products.
- Provide Quality Engineering support in the form of Design Controls, Design and Process Risk Management Activities, Supplier Quality to effectively drive reasonable and appropriate risk controls.
- Represent Quality on the cross-functional teams that handle resources and project priorities across the portfolio.
- Drive continuous improvement activities within the Franchise Quality Group and PD.
- Support franchise level Quality initiatives as the Quality Champion.
- Support 3rd party assessments as a subject matter expert / front room participant (FDA, ISO etc).