Staff Source Quality Engineer

About the role

The Staff Source Quality Engineer provides global Source Quality leadership for direct and indirect suppliers and external manufacturers supporting Johnson & Johnson products. This role leads the deployment and execution of Source Quality Management strategies, supplier controls, and risk-based quality oversight to ensure supplier qualification, performance, change management, and Approved Supplier List management.

Responsibilities

• Provide global Source Quality Management support by leading supplier and purchasing controls, including supplier selection, qualification, monitoring, change management, and Approved Supplier List management.
• Partner with suppliers and cross-functional stakeholders to investigate, resolve, and prevent supplier-related quality issues, minimize business disruptions, and support robust materials, products, processes, and systems.
• Monitor supplier performance, analyze quality data and trends, communicate risks, and drive quality risk management, corrective actions, targeted improvements, and supplier relationship management activities.
• Lead supplier quality projects, component qualification changes, quality agreements, and process/product improvement initiatives using project management, Quality Engineering, and continuous improvement tools.
• Ensure compliance with applicable quality system, regulatory, environmental, health, safety, and company requirements while communicating business issues and opportunities to management.

Qualifications

• Education: A bachelor’s degree in Engineering, Applied Science, or a related technical or quality field required.
• Required Experience and skills:
  • Minimum of 6 years in a highly regulated industry, with manufacturing, engineering and/or quality work experience.
  • Demonstrated ability to assess compliance risks and business impact, manage complexity, influence diverse teams, and resolve complex issues using deductive reasoning, critical analysis, and systematic approaches.
  • Working knowledge of regulatory compliance requirements, including QSRs, MDD, ISO 9001, ISO 13485, ISO 14971, or other applicable international standards.
  • Strong business acumen and ability to collaborate with all levels of management in a cross-functional team environment.
  • Experience with quality issue investigations, NCRs, CAPAs, analytical tools, metrics development, trend identification, and business/software applications including Word, Excel, PowerPoint, Minitab, Visio, and Microsoft Project.
  • Strong communication skills in English.
• Preferred Skills: Risk management, GxP, quality systems, supplier management, CAPA/non-conformance, technical writing, audit, component or process validation experience is preferred. Relevant certifications or training, such as ASQ CQE, CQM, CSQP, CQA, CBA, FPX, PMP, Six Sigma Black Belt/Green Belt, Lean, PE leadership training.

Benefits

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via this link, internal employees contact AskGS to be directed to your accommodation resource.