Source Quality System Lead

Ethicon LLC, member of the Johnson & Johnson’s Family of Companies, is recruiting for a Source Quality System Lead to be located in ETHICON manufacturing and/or ETHICON office sites in the United States, Puerto Rico, Mexico, or Brazil.
The Source Quality System Lead, under the supervision of the Source Quality Manager or Senior Source Quality Manager, will have the objective of continuously maintaining and improving the Purchasing Control Quality Systems. The Source Quality Systems Lead ensures the Quality System elements related to purchasing control meet the business and regulatory requirements. He/ she will also be responsible to lead and oversee for NC, CAPA, internal/external observations and Supplier Performance Monitoring activities as defined in Purchasing Control Quality Systems Procedures. Ensures effective communication and continuous education of Management and Control of Source Quality System processes.
Key Responsibilities
- Manage Source Quality systems, including but not limited to: document management program, Non-Conforming Record (NC) system, Corrective and Preventive Action (CAPA) system and QS Training
- Lead the Source Quality Data Review Board. Analyzes quality data and identifies trends impacting risks/benefits requirements of process, product and quality systems, and ensure appropriate escalation is pursued, as required
- Responsible for the proactive identification and alerting management of supplier quality related issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business
- Work effectively with the other site Quality System Leaders and business partners to ensure consistent/effective quality systems performance
- Perform other work-related duties as assigned by Source Quality Manager
- Lead projects related to Source Quality Systems
- Maintain regular interface with Management to assist in the development of Quality Metrics and to achieve company's Quality goals
- Own NCs, CAPAs, and Audit observations as required
- Lead the Purchasing Control Audit Readiness program
- Lead the Periodic Reviews/Forums to monitor performance of the Source Quality Systems
- Provide education/training regarding NC, CAPA and audit observation processes including Bounding and Failure Investigation/ Problem Solving, as needed
- Collaborates with Procurement/Sourcing and other business partners on system/process improvement projects and in the implementation of Purchasing Controls
- Responds proactively to emerging industry, regulatory, and business changes
- Ensures compliance to applicable Global Regulations and standards (e.g. QSR, ISO, EN, and Medical Device Directive (MDD) requirements, EU MDR)
- Performs other duties assigned as needed
**Qualifications**
- A minimum of a Bachelor's degree is required. A degree in Engineering and technical/scientific preferred.
- A minimum of 6 years of Quality/Engineering work experience is required.
- Practical experience with GMP documentation and writing skills in the FDA regulated environment is required.
- Working experience in a highly regulated environment (medical device, pharmaceutical, etc.) is preferred.
- Broad experience with GxP Quality Systems, including but not limited to investigations, qualification/validation, CAPA, NC, audit and Supplier/Purchasing Controls, and Supplier Quality Agreement is preferred
- Source Quality or Procurement experience is preferred
- People management/talent development experience desirable.
- Hands on strategy development and deployment experience is preferred
- General Understanding of regulatory compliance requirements (QSR, MDD, ISO 9001, ISO13485, ISO 14971 and other international standards) is required
- ASQ Certification: Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Supplier Quality Professional (CSQP), and/or Certified Six Sigma Black Belt (CSSBB) preferred
- J&J Flawless Project Execution (FPX) or Project Management Professional (PMP) Certification, and/or J&J Lean/Six Sigma Certification desirable
- Ability to work under own initiative with minimum supervision
- Excellent English verbal/written communication and influencing skills required
- Proven business acumen
- Ability to collaborate with all levels of management in matrixed team environment is preferred
- Bilingual in English and other language (Spanish, German, Portuguese, or Mandarin) is preferred
Location and Travel Requirements
The primary location of the position to be based at ETHICON manufacturing and/or ETHICON office sites.
- This position may require up to 25% domestic and international travel.
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 discri

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