Johnson & Johnson is seeking a Senior Source Quality Engineer to be located in Cornelia, GA.
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The Senior Source Quality Engineer (Sr. SQE) provides overall quality assurance leadership in the management of Direct, Indirect Suppliers and/or External Manufacturers engaged in the production of Johnson and Johnson products. The Sr. SQE will be responsible for external suppliers of direct and indirect materials, finished goods and services for the Ethicon franchise. He/she 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.
This individual will leverage talents and coordinate teams (SQEs and others), collaborate with Strategic Sourcing/Procurement, R&D, Engineering/Technical Operations, Quality, Operations, business partners/stakeholders, and external suppliers to implement solutions and improve suppliers' quality and overall service and performance. In this role, the individual supports the execution of plans/strategies, and implementation of systems, processes, and procedures to ensure robust supplier/purchasing controls with regards to the determination, selection, qualification, monitoring, and disengagement of suppliers.
Key Responsibilities:
- 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.
- Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
- Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects.
- 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.).
- Lead component qualification change projects in collaboration with key business partners and the supplier's applicable functional groups.
Qualifications
Education:
- A minimum of a Bachelor's degree in Engineering, an Applied Science or a related technical and quality field is required.
Experience:
Required:
- A minimum of 2 years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation
- Prior manufacturing, plant or technical background
- Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls
- Experience with documentation and technical writing skills, in a regulated compliance environment
- Demonstrated ability to identify compliance risks and assess business impact,
- Working knowledge 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:
- Working experience in good manufacturing practice regulated environment (medical device, pharmaceutical, etc.).
- Demonstrated knowledge of manufacturing principles and practices, and procedures.
- Direct experience in plant and/or supplier GMP auditing.
- Ability to manage complexity and work in a diverse team environment is essential.
- Working knowledge of Quality issue investigation, Non-Conformance Reports (NCRs), Corrective and Preventative Actions (CAPAs)
- ASQ Certifications for Certified Quality Engineer (CQE), Quality Manager (CQM), and/or Supplier Quality Professional (CSQP)
- Quality Auditor qualifications or Lead Auditor certifications such as ASQ Certified Quality Auditor (CQA) or Biomedical Auditor (CBA)
Other:
- Ability to communicate effectively in English is required. Bilingual in English and other language (Spanish, German, Portuguese, or Mandarin) is preferred.
- The primary location of the position is to be based at ETHICON manufacturing site located in Cornelia, GA.
- 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 discriminated against on the basis of disability.
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.