Collaborate closely with the OEM/CM suppliers and internal stakeholders to support supplier performance across quality, service, and cost dimensions. Act as the primary liaison between Stryker and OEM/CMs to ensure suppliers consistently meet technical, regulatory, and business requirements.
Manage and execute PPAP (Production Part Approval Process) activities for New Product Introductions (NPIs) and post-launch production, including manufacturing transfers and process stabilization.
Partner with cross-functional teams during product development and design changes to ensure supplier readiness and adherence to quality deliverables.
Lead structured problem-solving efforts (e.g., 8D, 5 Whys, DMAIC, Cause & Effect) to drive effective root cause analysis and corrective action implementation for supplier-related quality issues (NCs, CAPAs).
Promote and apply continuous improvement tools such as Lean, Six Sigma, Poka-Yoke (error-proofing), Measurement System Analysis (MSA), Statistical Process Control (SPC), and Process FMEA (pFMEA) across the supply base.
Coordinate supplier-driven changes through formal change control processes to ensure seamless implementation and compliance.
Review and approve supplier validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), special process validations, and test method validations.
Manage First Article Inspections (FAIs) for both sustaining parts and development projects, ensuring alignment with engineering and quality requirements.
B.Tech (Electronics/Electrical/Mechanical) with 2-5 years of experience in Quality / Engineering / Manufacturing environment.
Quality Processes/ Tools - Working knowledge of basic and advanced Quality tools such as; PPAP, Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, Lean Manufacturing etc.
Executes/implements/ improve all supplier quality tools/ Processes. Trains supplier in these tools effectively.
Proficient in MS Office Suite (including Word, Excel, Power Point etc).
Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory affairs).
Understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820, or comparable standard / regulation) and EU's Medical Device Directive.
Excellent communication and influencing skills, with the ability to manage multiple tasks and represent the Quality function across teams
Preferred ASQ Certified Quality Engineer (CQE).
Commodity Domain Knowledge – Strong Knowledge & understands technology, regulatory requirement related to product, system & services.
Proven track record of leading successful process implementation projects
Travel Percentage: 20%
Top Skills
What We Do
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.
Together with our customers, we are driven to make healthcare better.
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