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.

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 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.

Qualifications:

- 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.

Background check and drug screen are required.

Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

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).