Supplier Quality Engineer
HybridGurugram, Haryana, India
Job Summary
Ensure compliance with supplier management activities and manage production cycles post-new product launches. Participate in cross-functional teams to meet customer requirements while applying systematic problem-solving methodologies like 5Why, DMAIC, and 8D to resolve quality issues. Evaluate quality data to identify supply chain improvement opportunities and coordinate change management with suppliers. Inspect materials, equipment, and processes to validate quality specifications, deliver First Article Inspections, and implement continuous improvement methodologies such as Lean, Six Sigma, and SPC. Prioritize reviewing and delivering validations including IQ, OQ, and PQ. B.Tech degree with 2-5 years of quality experience required; 10% travel expected.
Required Qualifications
- B.Tech (Electronics/Electrical/Mechanical)
- 2-5 years of experience in Quality / Engineering / Manufacturing environment
- 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.
- 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)
- Travel Percentage: 10%
- 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
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