Johnson & Johnson Health Care Systems Inc., is currently recruiting for a Senior Commercial Quality Engineer to be located in Mooresville, Indiana
Johnson & Johnson Health Care Systems Inc. (JJHCS) provides contracting, supply chain, business services, and strategic solutions to customers and commercial intermediaries of U.S.-based Johnson & Johnson companies, including hospital systems, health plans, distributors, wholesalers, purchasing organizations, government payer programs, and government healthcare institutions in the U.S. JJHCS also engages with customers to provide streamlined supply chain services for our products that seamlessly integrate with customer operations, address shared evolving market challenges to value-based care, and develop innovative solutions that improve patient care and access. *CareAdvantage, Johnson & Johnson Family of Companies, is offered through Johnson & Johnson Health Care Systems Inc. Its Supply Chain Optimization capability is provided for Johnson & Johnson Medical Devices Companies products.
The Senior Commercial Quality Engineer is responsible for: This individual will be accountable for meeting customer and business needs in compliance with regulatory requirements, Enterprise Standards, Quality Management Systems at the Medical Device Distribution Center Mooresville in the United States.
This position serves as a liaison with Quality and Supply Chain partners, Deliver Quality related matters, and collaborates with the franchise and Deliver organizations to drive timely resolution of Quality related issues. This position identifies opportunities to continuously improve quality and compliance consistent with Deliver business objectives. The Sr. Compliance Specialist supports proposals and quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through workstream groups.
The Senior Commercial Quality Engineer is responsible for supporting quality and compliance activities at the MD Distribution Center in Mooresville and participating in NC investigations and performing audit activities.
PRINCIPAL RESPONSIBILITIES Compliance • Work with Regional Deliver Quality team to ensure QMS metrics are provided in a timely manner for both • Deliver Quality & Compliance and 3PL. • Coordinate and assist in Supplier Audits associated with the site, as required. • Support all internal (JJRC) and external Health Authority inspections (e.g. VAWD, FDA, TUV/BSI) and any other logistics and transportation related inspections (e.g., TSA) conducted at all sites. • Ensure the Quality program maintains regulatory compliance. • Accountable to support and execution for all distribution and inventory management activities (e.g. receiving, pick, pack, lot reconciliation, reverse distribution, destruction process, quarantine, hold, stop-ship, recall, refusals, donations, destructs authorization, discontinuation, returns, disposal, etc.) • Accountable for execution of robust product disposition procedures and the quality oversight of all product quality holds, stock removal, stop ship extension and field actions impacting the Distribution Center. • Responsible to support the company's quality and distribution process capabilities against company and industry standards and regulatory expectations. • Responsible to support for monitoring of calibration and preventive maintenance systems.
Operational • Support execution of the Quality System. • Oversight of Quarantine/Hold/Stop-Ship/Recall processes. • Ensure returned product is dispositioned according to predefined agreements with Operating Company, Franchise, or Marketing Co. • Assist in the development, implementation, and review of standard operating procedures for interactions with contract distribution providers. • Supporting Quality management of repacking, relabel, kitting, and reprocessing operations conducted within the DC
System/Process • Execution of the change control process. • Trending of service-related complaints. • Provide resolution and metric reporting of CAPA, NC, and audit observations, as applicable. • Responsible to support the appropriate handling of distribution related customer complaints • Responsible for escalation management to Make QA/BQ and Franchise QA as well as commercial business organizations and Deliver operations partners. • Create, review and approve assessment plans, risk assessment reports, non-conformance reports, corrective and preventative actions, audits, and other documentation. • Support leadership and compliance activities including, but not limited to the creation and revisions of global and local procedures. • Support the evaluation of overall compliance risk, recommend corrective actions and track progress.
Education and Experience: • A Bachelor's degree in scientific related field or quality regulatory compliance disciplines is preferred, or related experience. • A minimum of 3 years of regulated industry experience in distribution, transportation, temperature control, manufacturing, operations, regulatory and/or quality compliance is required.
Knowledge, Skills, and Abilities: • Business experience in regulated industry in a fast paced, dynamic, global operation is required, while experience in health care industry and/or medical device loaner kit operations is preferred. • Experience within a diverse organization and must be able to actively conduct benchmarking assessments and develop action plans to drive improvements accordingly. • Must be able to develop and administer a strategic audit plan for 3PLs that optimizes compliance and minimizes customer risk. • Experience with investigations and audit remediations preferred. • Experience with an investigation system a plus • Documentation experience preferred • 3 party logistics experience preferred • The following skills and attributes are highly desired: innovative mindset, project management, change management, knowledge management, technology and data management, quality mindset, global mindset, influencing, analytics and problem solving, decision making, compliance orientation, business case development, and a drive for continuous improvement.
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.
United States-Indiana-Mooresville-9440 South State Road 9
Johnson & Johnson Health Care Systems Inc. (6077)
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