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.

Overall responsibilities:

• 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).

Qualifications

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).

Required

Education:

• Bachelor of Science Degree in Engineering or other related discipline and/or Sciences

Experience:

• A minimum of 8 years of experience
• Experience within a medical device manufacturing company
• Previous experience should demonstrate success, as a quality professional with supervisory responsibility for both people and projects is required.
• Requires a strong knowledge of medical devices, FDA - QSR’s, ISO 13485:2016, Statistics, Risk Management and Design Controls.
• This candidate must be able to communicate effectively at all levels within Quality as well as cross-functionally to provide Quality leadership.
• A proven track record is required to show candidates experience motivating and developing direct reports as well as coach/mentor other professionals, as well as peers.
• Excellent remote management communication and team building skills.
• Excellent problem solving and decision-making skills.
• Interpersonal skills that foster conflict resolution as it relates to technical situations.
• Strong influencing and negotiation skills without direct line authority

Preferred:

• A Master’s Degree
• Working knowledge related to orthopedic implantable, product software and software validation
• Six Sigma/Process or Design Excellence training, and/or certification
• Strong working knowledge of Analytical Tools and Advanced Statistical Analysis

Other:

• 20% Travel (US only)

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At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.