Work Flexibility: Hybrid
What will you do:
• Partner with Global Supplier Quality and Strategic Sourcing on the development, negotiation
and approval of Quality Agreements, and Change Control Agreements with suppliers.
• Leading External Supplier Audits to ensure regulatory compliance in area of responsibility.
• Supporting / Leading Acquisitions and Due diligence activities.
• Supporting / Leading Stryker M&A Distribution deals / Stock deals covering QIPs/CAPA and
lead Investigation end to end.
• Define strategy & execution for Audit adoptions/CCA adoptions/SQA adoptions.
• Participate in Stryker's supplier QMS audit program - planning, execution, and closure of
audits.
• Participate in cross-functional teams in the development of new products or changes related
to current products in meeting customer requirements.
• Applies sound, systematic problem-solving methodologies (5Why, DMAIC, 8D, C&E) in
identifying, prioritizing, communicating, and resolving quality issues - NC & CAPA.
• Conduct Supplier Audits (Product, Process & System) and Facilitate root cause analysis and
corrective actions of supplier quality issues.
• Evaluating Quality data to identify process improvement opportunities within the supply
chain.
• Coordinate Change Management & Control with Suppliers and implement changes at
Suppliers.
• Promote the use of continuous improvement methodologies such as Lean, Six Sigma, Poka-
Yoke (Error Proofing), Measurement System Analysis (MSA), Statistical process control (SPC)
and Process Failure Mode and Effects Analysis (pFMEA).
• Review development protocols including Installation Qualification (IQ), Operational
Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test
Method Validations.
• Input into local, global & corporate processes, a representative on review & discussion boards
and teams for expert & valued input.
• Supplier Assessment for internal and External Integrations which includes review of QPR, NC/CAPA, SICR, SQA and Audit data.
What you need