Source Quality System Leader

Ethicon LLC, member of the Johnson & Johnson’s Family of Companies, is recruiting for a Source Quality System Leader to be located in ETHICON manufacturing and/or ETHICON office sites in Cornelia, GA, or Guaynabo, PR. Alternate locations include Raritan, NJ, São José dos Campos, Brazil, and Juarez, Mexico.
The Source Quality System Leader, under the supervision of the Senior Source Quality Manager or Source Quality Director, 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
- Drive the improvement and development of the quality system strategy for the Source Quality Management function.
- Manage Purchasing Controls quality systems, including but not limited to: Nonconformance Reporting (NCR) and Corrective and Preventive Actions (CAPA), document management, training program, management review, complaints management activities and records management.
- Responsible for the overall management and effectiveness of the NCR and CAPA processes, including facilitation of the relevant data review forums for Source Quality and representation on the worldwide NCR and CAPA Teams.
- Lead quality systems improvements, which result from Internal / External Audits, Management Review and or any other CAPA / NCR systems indicators.
- Maintain regular interface with local Management to achieve company's Quality goals.
- Work effectively with other Sites Quality Systems Leaders to ensure consistent systems and processes.
- Coordinate, maintain and control the document retention and preservation notices as per enterprise, franchise, and regulatory requirements.
- Provide routine communication and updates to site, franchise and enterprise organizational management regarding quality systems trends and initiatives.
- Develop and implement measures to monitor the effectiveness of the applicable quality systems.
- Report Quality system Scorecard results to the Source Quality management team, franchise management, and any other required function, as applicable.
- Lead projects related to Quality Systems as required.
- Support Corporate Quality Advancement Strategies.
- Review and disposition document changes within areas of expertise per applicable procedures.
- Provide education and mentoring as needed regarding quality systems.
- Provide support and guidance to key individuals and teams to assure compliance with minimum impact to the organization.
- Perform other work-related duties as assigned by the SQM Team.
**Qualifications**
Experience and Education
- Bachelor’s Degree in Science, Engineering or another technical field is required.
- At least five (5) years of experience in the QSR/ISO regulated industry. Medical devices preferred.
- Experience in the Medical Device industry or medical field.
- Demonstrated knowledge of manufacturing principles and practices, and procedures.
- Ability to communicate effectively with cross-functional teams.
- Ability to perform duties in accordance with policies and procedures and in compliance with civil rights requirements.
Required Knowledge and Skills
- General Understanding of regulatory compliance requirements (QSR, MDD, ISO 9001, ISO13485, ISO 14971 and other international standards) is required
- ISO Lead Auditor or Lead Assessor Certification, preferred.
- Proven ability to initiate and implement Quality System changes.
- Strong technical writing skills are required.
- Strong Project management skills.
- Ability to work under own initiative with minimum supervision
- Excellent English verbal/written communication and influencing skills required
- 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 in **Cornelia, GA, or Guaynabo, PR**. Alternate locations include Raritan, NJ, São José dos Campos, Brazil, and Juarez, Mexico.
- This position may require up to 25% domestic and international travel.
- Relocation assistance is not available for this role.
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

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