Sr Quality Engineer

IndiaFull-TimeSenior
Salary not disclosed
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Job Details

Experience
5 to 7 years
Required Skills
Quality Assurance

Requirements

  • Bachelor's degree in Chemical Engineering, Biotechnology, Production Engineering, Pharmacy, or a related discipline; Master's degree is advantageous.
  • Minimum of 5 to 7 years of experience leading teams within Quality Assurance or Supplier Quality Assurance environments.
  • Lead Auditor certification in ISO 9001, ISO 13485, or other relevant quality standards.
  • Extensive experience conducting ISO and GMP audits through both onsite and remote methodologies.
  • Strong understanding of Lean methodologies and Six Sigma principles; Green Belt certification is an advantage.
  • Hands-on experience with Root Cause Analysis tools, supplier quality management processes, and continuous improvement methodologies.
  • Familiarity with SAP, electronic Quality Management Systems (eQMS), and data analytics tools.
  • Excellent written and verbal communication skills with strong stakeholder management capabilities.
  • Strong analytical and problem-solving abilities.
  • Ability to work independently and collaboratively within cross-functional and international environments.

Responsibilities

  • Lead, mentor, and develop a team of Supplier Quality Engineers, ensuring effective execution of supplier quality initiatives and audit programs.
  • Allocate and prioritize team activities based on business requirements, risk assessments, and resource availability.
  • Monitor team performance through defined KPIs, including audit closure timelines, supplier corrective action effectiveness, and supplier performance metrics.
  • Provide technical guidance on quality methodologies such as FMEA, Statistical Process Control (SPC), Root Cause Analysis, DMAIC, and validation practices.
  • Ensure alignment with global quality strategies, regulatory requirements, and organizational objectives.
  • Conduct and oversee supplier audits, review audit reports, approve corrective action plans, and validate supplier qualification documentation.
  • Collaborate with procurement, operations, research and development, and global quality teams to proactively resolve supplier-related quality issues.
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