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:

Job Sub Function:

Job Category:

All Job Posting Locations:

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 different regional Customer Quality organization on Distribution Quality related matters. It collaborates with the DePuy/Synthes and Customer Quality organizations to drive timely resolution of Quality related issues. This position finds opportunities to continuously improve quality and compliance consistent with Enterprise, Sector and business objectives. They will drive critical changes to business to ensure compliance and continuous improvement.

Key Responsibilities:

• Provides leadership for all aspects of the DPS Asset Management, leading change to accomplish the overall business, financial and quality objectives. Lead the DePuy Synthes Loaner standard and procedures/instruction related to loaner verification. Provides coaching, guidance and leadership for the Regional Customer Quality Loaner set SMEs.
• Ensure regular communication / alignment with the representatives of Deliver Operations, Commercial Quality, the LOCs and with all other involved business partners. Support all last mile projects impacting loaner/consignment model.
• Provides expert level technical support of JJRC audits and regulatory inspections from global health authorities, including any applicable follow up. Ensures audit readiness of all loaner distribution points requiring support from DePuy Synthes. Acts as a Loaner set SME for all regions.
• Make proposals and assist in the development of corrective action plans and monitor implementation including follow-up on closure of corrective and preventive actions (CAPA)
• Conduct investigations, collect data, analyze trends and prepare reports for assigned quality processes
• Lead the development, implementation and review of standard operating procedures for interactions with contract distribution providers

Qualifications

Education:

• Bachelors or equivalent university degree in Natural Sciences, Engineering or related field of concentration.

Experience and Skills:

Required:

• A minimum of least 7 years of directly relatable experience in an FDA regulated environment. As a minimum, 7 years proven experience in Supply Chain, Quality Assurance or Engineering, or Regulatory Compliance.
• Business experience in regulated industry in a fast paced, dynamic, global operation
• Experience in collaborating with commercial and sales/marketing teams to drive process improvements for the business.
• Skilled at building interdependent partnerships and internal and external relationships.
• Risk based and customer centric minded.
• Ability to influence others, managing competing internal customer priorities and dealing with ambiguity.

Preferred:

• Experience in health care industry and/or medical device loaner kit operations
• Experience in the development and deployment of a Quality System
• Preferred experience in Orthopedics Medical Devices Experience - Clinical, Regulatory, Quality and/or R& D related
• Project Management experience

Other:

• Ability to travel up to 20%