Staff Source Quality Engineer

Johnson & Johnson Innovative Medicine•Guaynabo, PR

1d•Hybrid

About The Position

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, issue resolution, and continuous improvement are conducted in alignment with applicable regulatory requirements, quality system standards, and business objectives. The Staff SQE partners with suppliers and cross-functional stakeholders to strengthen supplier capability, prevent quality and compliance risks, and support a reliable, compliant, and resilient supply base for Ethicon Supply Chain suppliers.

Requirements

A bachelor’s degree in Engineering, Applied Science, or a related technical or quality field required.
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.

Nice To Haves

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.

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.