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 – Solid Knowledge & understands technology, regulatory requirement related to product, system & services.
- Proven track record of leading successful process implementation projects

📌 Quality Engineer (Gurugram)
🏢 Stryker
📍 Gurugram