Supplier Quality Engineer
Stryker · Gurgaon, Haryana, India ·
- Work mode
- Onsite
- Category
- Industrial engineering
- Experience
- 2+ years
- Company size
- 1000+
Ensures supplier quality for medical devices by auditing processes, resolving defects, and enforcing compliance with ISO 13485 and CFR 820 using Six Sigma and PPAP tools.
Ensuring compliance to Supplier management activities identified by organization.
Experience of PPAP associated with New Product Launches and Management of Production cycles there after (Manufacturing Transfers).
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 to facilitate root cause analysis and corrective actions of supplier quality issues.
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)
Evaluate Quality data to identify process improvement opportunities within the supply chain.
Coordinate Change Management & Control with Suppliers and implement changes at Supplier.
Review of process and equipment Validation including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test Method Validations.
Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met.
Prioritizing, reviewing, and delivering First Article Inspections FAIs for sustaining parts and development projects.
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).
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.