Manager, Supply Chain Quality

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Palm Beach Gardens, Florida, United States of America

Job Description:

We are searching for the best talent for Manager, Supply Chain Quality to join our DePuy Synthes Quality and Compliance organization located in Palm Beach Gardens, FL.

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

The Manager, Supply Chain Quality will be accountable for the Operational Quality support of manufacturing and ancillary processes in the Palm Beach manufacturing site. This includes the execution and delivery of quality strategies for sustaining engineering and supporting the manufacturing of Power tools and medical equipment/robotics. This individual should be willing to make a significant contribution to a multi-disciplined team, be self-motivated to act, and have excellent written and verbal communication skills.

Key Responsibilities:

• Partner with Operations, Regulatory, and Research to assure all sustaining engineering and Operation quality deliverables are met in accordance with all regulatory standards (e.g. FDA 21 CFR Part 820, ISO13485, EU MD Directive/Regulations, Japan JPAL, Canada CMDCAS, Brazil ANVISA, Australia TGA and all other applicable regulatory standards considering the countries/regions products are marketed.) within cost, quality, and schedule targets.
• Manage the Operation Quality engineering resources and allocate projects as needed to support business objectives.
• Excels as Supply Chain Quality processes such as CAPA, Change Management, and escalation.
• Can discuss and defend documents and processes proficiently in front and back room during internal and external audits
• Monitor quality metrics across the business unit to identify systemic product and process issues, assuring appropriate investigation, correction, and corrective and preventive action when needed.
• Is able to identify and execute improvements on the Quality systems and execution thereof as it relate to improving the quality and compliance of the product, and the operational effectiveness.
• Partner with R&D, Operations, and Regulatory to assure there is appropriate execution of risk management and design controls and process validation for new and existing products.
• Know and follow all laws, standards, and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times.
• Diligently participate in compliance program-related activities as denoted by leadership or our Compliance experts.
• Promote and nurture the highest standards of professionalism, ethics, and compliance, and actively support our compliance program-related initiatives and activities.
• Consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance.
• Develop team talent and competency.
• Provide leadership in all areas of the Quality System beyond the support of production, such as product complaints, post market surveillance, nonconforming materials, risk management.
• Provide leadership in the understanding of medical device regulations to other disciplines.
• Communicate effectively at all levels, bo