Quality Engineer

What You will do:

• 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.

What You will Need:

Required Qualification:

• 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).

Preferred Qualification:

• 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