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 Assurance
Job Category
People Leader
All Job Posting Locations:
Blackpool, Lancashire, United Kingdom, Leeds, West Yorkshire, United Kingdom, Little Island, Cork, Ireland, Suzhou, Jiangsu, China
Job Description
DePuy Synthes is recruiting for a DePuy Synthes Loaner Quality Lead, located at a MedTech site in one of the following locations: Raynham, MA; Bridgewater MA; Warsaw IN; Palm Beach Gardens FL; Raritan NJ; Cork Ireland; Suzhou China; West Chester, PA or Leeds/Blackpool UK.
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.
This position leads the Franchise Customer Quality for DePuy Synthes and is accountable for the loaner business model, ensuring execution is done appropriately within the different regions. This position serves as a liaison with the Supply Chain and Commercial partners, and the regional Customer Quality organization on Distribution Quality matters. It collaborates with DePuy/Synthes and Customer Quality organizations to resolve Quality issues promptly. The role involves identifying opportunities for continuous improvement in quality and compliance aligned with enterprise and sector objectives, and implementing critical business changes to ensure compliance and ongoing improvement.
Key Responsibilities
Provides leadership for all aspects of the DPS Asset Management, leading change to meet business, financial, and quality objectives. Leads the DePuy Synthes Loaner standard and procedures related to loaner verification. Coaches and guides Regional Customer Quality Loaner SMEs.
Ensures regular communication and alignment with Supply Chain, Commercial Quality, LOCs, and other business partners. Supports last mile projects affecting the loaner/consignment model.
Provides expert support during JJRC audits and regulatory inspections, ensuring audit readiness across all loaner distribution points. Acts as a Loaner set SME for all regions.
Proposes and assists in developing corrective action plans, monitors their implementation, and follows up on CAPA closure.
Conducts investigations, data collection, trend analysis, and reporting for quality processes.
Leads the development, implementation, and review of SOPs for interactions with contract distribution providers.
Qualifications
Education
Bachelor’s or equivalent degree in Natural Sciences, Engineering, or related field.
Experience and Skills
At least 7 years of experience in an FDA-regulated environment, with proven experience in Supply Chain, Quality Assurance, Engineering, or Regulatory Compliance.
Experience in a fast-paced, global regulated industry.
Experience collaborating with commercial and marketing teams to improve processes.
Strong partnership-building skills and relationship management.
Risk-based and customer-centric mindset.
Ability to influence, manage priorities, and deal with ambiguity.
Preferred
Experience in healthcare industry and/or medical device loaner operations.
Experience developing and deploying Quality Systems.
Experience in Orthopedics Medical Devices, including Clinical, Regulatory, Quality, or R&D.
Project Management experience.
Other
Ability to travel up to 20%.
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