Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
The Sr. Staff Supplier Quality Specialist serves as a Supplier Quality systems subject matter expert, leading Supplier Quality Management processes, projects, governance, metrics, process improvements, and documentation strategy. The role partners with Supplier Quality, Procurement, Quality, Operations, Engineering, IT, and business leaders to improve process effectiveness, compliance, scalability, and data-driven decision-making.
DESCRIPTION
Supplier Quality Management Process Strategy:
- Provide senior SME leadership for Supplier Quality Management processes, governance, metrics, documentation, and process controls across sites or business units.
- Set strategy for harmonized supplier qualification, monitoring, issue management, supplier change control, Quality Agreements, PPAP governance, supplier audit planning, and process effectiveness reviews.
- Translate regulatory, QMS, business, and stakeholder requirements into scalable Supplier Quality processes and technology-enabled solutions.
Strategic Projects, Systems, and Transformation:
- Lead complex, cross-site Supplier Quality process transformations, system improvements, data governance initiatives, and continuous improvement portfolios.
- Develop improvement roadmaps, business cases, risk assessments, stakeholder alignment plans, and sustainment mechanisms.
- Use analytics, dashboards, and leading indicators to reduce supplier quality risk, improve process cycle time, and reduce cost of poor supplier quality.
Governance, Influence, and Mentoring:
- Advise Supplier Quality and business leaders on process risks, controls, metrics, and improvement priorities.
- Lead governance reviews, escalation forums, audit readiness activities, and process health assessments.
- Mentor specialists and engineers; provide expert guidance on PPI, RCCM, change management, and Supplier Quality systems practices.
REQUIREMENTS
Education:
- Bachelor's degree in Engineering, Manufacturing, Operations Management, Biological Sciences, Chemistry, Business, or equivalent combination of education and experience required for professional, management, and leadership roles; associate degree or equivalent technical experience may be acceptable for associate roles.
- Quality auditor training preferred for bands 4-6; quality lead auditor training preferred or required for advanced professional roles depending on business need.
- Experience with QMS processes, documentation systems, data analysis, dashboards, project coordination, and continuous improvement tools preferred.
Experience:
- Typical experience: 8+ years in Supplier Quality, Quality, Manufacturing, Operations, Engineering, Business Process, or related functions.
- Equivalent combinations of education, experience, and demonstrated capability may be considered based on business needs.
Knowledge, Skills, and Abilities:
- Working knowledge of ISO 9001 and applicable industry standards; experience with ISO 13485, 21 CFR Part 820, 21 CFR Part 210/211, ISO 14971, MDSAP, or other applicable requirements preferred based on business context.
- Knowledge of Supplier Quality Management processes, QMS documentation, process governance, project management, change management, and practical process improvement methods.
- Strong written and oral communication skills with the ability to collaborate across functions and build effective relationships with suppliers, internal customers, and stakeholders.
- Ability to analyze data, summarize results, generate metrics, identify risks, and drive improvement actions.
- Detail-oriented, organized, accurate, self-motivated, adaptable, and able to prioritize work to meet business objectives.
- Demonstrated ability to mentor colleagues, influence stakeholders, and lead complex or cross-functional improvement initiatives.
Physical Requirements / Work Environment:
- May sit or stand for long periods and walk between buildings or to production, laboratory, warehouse, or office areas.
- Close vision is needed to read documents, quality records, and computer screens.
- May lift up to 15-20 lbs. as business needs require.
- Travel by air, train, or car may be required; supplier-facing and leadership roles may require up to approximately 30% travel depending on business needs.