Senior Source Quality Engineer.

Ethicon, member of the Johnson & Johnson’s Family of Companies is recruiting for a Senior Source Quality Engineer to be based at Raritan or any Johnson and Johnson medical device locations.

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and energy devices—that are used in a wide variety of minimally invasive and open surgical procedures.

The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation.

Ethicon, Inc.

based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery.

Ethicon Endo-Surgery, Inc.

was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

The Senior Source Quality Engineer (Sr.

SQE) provides overall quality assurance leadership in the management of External Manufacturers engaged in the production of Johnson and Johnson products.

The Sr.

SQE will be responsible for external suppliers of finished goods and services for the Ethicon franchise.

The candidate leads the deployment of the Source Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the Ethicon supply chain.

The primary location of the position to be based at ETHICON manufacturing and/or ETHICON office sites.

Responsibilities Summary Provide timely business support for the assigned Ethicon Source Quality Management (SQM) function globally.

Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management.

Participate in and/or support the identification, selection, qualification, monitoring, and disengagement of suppliers for Source Quality Management.

May lead this process under the guidance of Source Quality Manager and/or management representative.

Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.

Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.

Supervise and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.

Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.

Own, drive, and lead the assigned Source Quality related projects, activities, initiatives with limited supervision.

Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts Own and lead the Source Quality Relationship Management (SQRM) process for the assigned suppliers (e.g.

Lead periodic SQRM meetings including supplier quality performance reviews, supplier investigation follow-ups, investigation responsiveness/cycle time, targeted improvement plans (TIP), closed loop corrective actions, NC reductions, supplier quality metrics, etc.).

Take actions to identify internal customer requirements and translate customer requirements into potential proactive improvements to components or supplier quality systems.

Proactively pursue clarification to confirm understanding of internal customer needs and requirements.

Follow up on commitments and keeps customer, management and appropriate parties apprised.

Respond proactively to changing regulatory and business needs.

Lead component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups.

Apply appropriate Quality Engineering and PEx tools to support innovations and continuous improvements Responsible for presenting business related issues or opportunities to next management level.

Qualifications A minimum of a Bachelor’s degree in Engineering, an Applied Science or a related technical and quality field is required.

A minimum of 4 years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation is required.

Prior manufacturing, plant or technical background is required.

Demonstrated ability to identify compliance risks and assess business impact, is required.

Solid understanding of regulatory compliance requirements (i.e.

Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards) preferred.

Must have strong business acumen.

The ability to collaborate with all levels of management in cross-functional team environment.

Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls, is required.

Experience with documentation and technical writing skills, in a regulated compliance environment, is required.

Working experience in good manufacturing practice regulated environment is preferred (medical device, pharmaceutical, etc.).

Direct experience in plant and/or supplier GMP auditing is preferred.

Component Qualification/Process Validation experience is preferred.

New product introduction experience is desired.

Prior experience with FDA inspections is desirable.

Ability to communicate effectively in English.

This position may require up to 25% domestic and international travel.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location United States-New Jersey-Somerville
– Other Locations North America-United States-California-Redwood City, North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-Pennsylvania-West Chester, North America-United States-California-Irvine, North America-United States-Georgia-Atlanta, North America-United States-Massachusetts-Raynham, North America-United States-New Jersey-Raritan Organization Ethicon Inc.

(6045) Job Function Engineering Requisition ID 2105959366W