We are seeking a highly experienced and technically proficient Procurement Supplier Quality Engineer to serve as a Technical Lead. This critical onsite role will be responsible for leading and managing process validation, verification, and qualification activities at our plastic suppliers. The ideal candidate will possess strong Manufacturing
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Engineering and Design expertise to meticulously review product and part specifications in collaboration with R&D and Design Assurance, ensuring alignment with part/product risk management files. This role requires a hands-on approach to driving and performing Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV) directly at supplier sites. Excellent communication skills are paramount, as this individual will be responsible for managing stakeholders and providing comprehensive bi-weekly updates to Senior Leadership.
This position will involve a minimum of 20% travel within North America.
Responsibilities:
- 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.
Skills:
- 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 ap
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Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including health, and an incentive and recognition program (all benefits are based on eligibility).