Lead Quality Improvement Specialist

19 hours ago

Gurgaon, Haryana, India beBeeQuality Full time ₹ 1,04,000 - ₹ 1,30,878
Senior Quality Assurance Specialist

Job Description:

  • Ensure adherence to quality control activities designated by the organization.
  • Experience with PPAP associated with new product launches and management of production cycles thereafter (manufacturing transfers).
  • Collaborate with cross-functional teams in the development of new products or changes related to current products in meeting customer requirements.
  • Apply 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 the supplier.
  • Review of process and equipment validation including installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), special process validations, and test method validations.
  • Prioritize, review, and deliver first article inspections FAIs for sustaining parts and development projects.

Required Skills and Qualifications:

  • 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.
  • Execute/implement/improve all supplier quality tools/ processes. Train suppliers in these tools effectively.
  • Proficient in MS Office Suite (including Word, Excel, PowerPoint 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.

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