Johnson & Johnson MedTech · 1 day ago
Manager, Supply Chain Quality
Palm Beach Gardens, FL
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, focused on developing personalized treatments for complex diseases. The Manager, Supply Chain Quality will oversee operational quality support for manufacturing processes, ensuring compliance with regulatory standards and leading quality improvement initiatives.
Hospital & Health Care
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, both within Quality and cross functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing
Qualification
Required
A minimum of a bachelor's degree is required
A minimum of 8 years related working experience in a GMP and/or ISO regulated industry with a minimum of 3 years people management or project management experience is required
Strong working knowledge of QSR (21 CFR 820), ISO (13485, 14971), and all country specific regulatory requirements is strongly preferred
Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations
Candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goals
Proficiency with the Microsoft Office Suite is required
Ability to effectively present complex information in a clear and concise manner is required
Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details is required
Experience of developing concise and audience-focused communications, both written and for presentations is required
Can manage through urgent unplanned topic with professionalism
Excellent communication and interpersonal skills are required
Preferred
A degree in engineering and/or in a technical science is a plus
A master's degree is a plus
Strong Quality engineering or Quality operations skills with a proven track record in design transfer Operation support, Process Validation, and product risk management is preferred
Previous experience in a medical device or a healthcare discipline is strongly preferred
Knowledge of process and design excellence tools is strongly preferred. Certification is a plus
Previous experience managing multiple projects is preferred
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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