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QMS Engineer

2 weeks ago

Mysore, Karnataka, India Operations EMS Full time ₹ 9,00,000 - ₹ 12,00,000 per year
Position: QMS Engineer
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Job Summary:

We are seeking a highly skilled and experienced Quality Management System (QMS) Engineer to join our team in the Electronics Manufacturing Services industry. The ideal candidate will have a strong background in implementing and maintaining QMS processes, with a focus on ISO 13485, AS9100, and preferably NadCap. This role demands a proactive individual with excellent communication skills, attention to detail, and a strong commitment to quality and compliance.

Key Responsibilities:

  • Develop, implement, and maintain QMS in accordance with ISO 13485, AS9100, and other applicable industry standards.
  • Lead internal audits, coordinate external audits (certification, customer, regulatory), and follow up on corrective and preventive actions (CAPA).
  • Manage documentation and control processes for QMS, ensuring accuracy, version control, and accessibility.
  • Work closely with cross-functional teams (engineering, production, supply chain) to ensure quality requirements are met throughout the product lifecycle.
  • Prepare for and manage certification and surveillance audits, including gap analysis, documentation review, and auditor coordination.
  • Drive continuous improvement initiatives and support root cause analysis for quality issues.
  • Maintain metrics and reports related to QMS performance, non-conformities, audit findings, and corrective actions.
  • Stay up to date with changes in quality standards, customer requirements, and regulatory updates.
  • (Optional but preferred) Support NadCap audit preparation and compliance activities.

Qualifications and Experience:

  • Bachelor's degree/diploma in Engineering or related technical discipline.
  • 6 to 8 years of experience in a QMS-focused role within an Electronics Manufacturing Services (EMS) or similar high-reliability manufacturing environment.
  • Strong working knowledge of ISO 13485, AS9100, and related quality standards.
  • (Optional) Experience with NadCap compliance or audit preparation.
  • Certified internal auditor for ISO 13485 and/or AS9100 is a plus.
  • Proficient in quality tools and methodologies (FMEA, Root Cause Analysis, 8D, CAPA, etc.).
  • Excellent verbal and written communication skills.
  • Strong organizational and documentation skills.