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.
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.

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.
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.
Relevant certifications or training, such as ASQ CQE, CQM, CSQP, CQA, CBA, FPX, PMP, Six Sigma Black Belt/Green Belt, Lean, PE leadership training.

Staff Source Quality Engineer

Key skills