procurement supplier quality engineer - technical lead.

- Lead and manage the end-to-end process validation and verification qualification activities at plastic suppliers and other critical commodity suppliers.- Leverage Manufacturing Engineering and Design expertise to review and assess product and part specifications against part/product risk management files in collaboration with R&D and Design Assurance teams.- Hands-on execution and oversight of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities at supplier facilities.- Provide technical guidance and support to suppliers in addressing Test Method Validation (TMV) challenges.- Conduct thorough reviews and assessments of supplier OQ/PQ/IQ documentation and processes.- Take ownership of the end-to-end assessment of Supplier Performance, including the management and analysis of Non-Conformances (NCRs), Supplier Quality Notifications (SQNs), Supplier Corrective Action Requests (SCARs), and Supplier Improvement Change Requests (SICRs).- Successfully integrate quality initiatives and strategies across multiple product lines and business units.- Maintain a thorough understanding of the supported business areas, including their strategic objectives, goals, competitive landscape, functional processes, and organizational dynamics.- Foster excellent cross-functional communication and collaboration, effectively integrating the work of various managers to achieve overarching business objectives.- Navigate and effectively drive resolution within ambiguous situations related to the Quality Management System.- Demonstrate strong communication skills, including the ability to present complex technical information clearly and concisely to diverse audiences.- Utilize statistical analysis tools and methodologies to evaluate supplier performance and identify areas for improvement.- Develop and deliver clear and concise PowerPoint presentations for updates to Senior Leadership and other stakeholders.- Maintain direct working relationships with suppliers, fostering collaboration and driving quality improvements.- Provide technical leadership and mentorship within the supplier quality function.- Apply project management best practices to plan, execute, and track supplier quality initiatives.- Leverage direct shop-floor production engineering and sustaining experience to effectively address supplier quality issues.

7-10 years

- Proven experience in leading and executing process validation (IQ, OQ, PQ) and Test Method Validation (TMV).- Demonstrated ability to interpret and apply relevant regulatory requirements (e.g., FDA, ISO).- Strong understanding of risk management principles and their application in a regulated environment.- Excellent problem-solving and analytical skills, including the application of statistical analysis.- Exceptional written and verbal communication and presentation skills.- Proven ability to effectively manage stakeholders at various levels.- Demonstrated leadership exposure in a technical capacity.- Proficiency in project management practices.- Direct experience in a shop-floor production engineering or sustaining role is highly desirable.

- Bachelor's degree in Engineering- Minimum of 10 years of related engineering experience, focused on Microengineering within a regulated industry is strongly preferred.- Broad cross-functional experience in areas such as Manufacturing Engineering, Design Engineering, or Quality Engineering.- Advanced knowledge and application of Quality Engineering principles and Continuous Improvement methodologies.- Ability to travel a minimum of 20% within North America.

Bachelors