Senior Quality Engineer

Work Flexibility: Hybrid

What You will do:

Key Responsibilities

• Ensuring compliance to Supplier Control 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 Need:

Must have Skills

• B.Tech (Electronics/Electrical/Mechanical) with 5-9 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).

Good to have Skills:

• 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.

Travel Percentage: 20%