Quality Manager Equipment

3 days ago

Madurai, India Aurolab Full time

As a Quality Manager you will be responsible for ensuring the company’s products meet all quality standards. Develop, implement, and maintain an ISO 13485-compliant Quality Management System. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the quality terms. Interact with external audit teams and conduct the audit peacefully. Help in MDR documentation & CE certification readiness from quality perspective. Facing internal & external quality audits and CAPA process.100% DHR compliance for traceability. Final goods performance yield tracking & sustenance. Implement non-conforming material process & resolve rework, scrap or return to vendor.

Key Responsibilities:

Quality Assurance:

  • Capture & improve in-process yield metrics
  • Final goods performance yield tracking & sustenance
  • Implement non-conforming material process & resolve rework, scrap or return to vendor
  • Understand parts, processes and performance
  • Implement engineering change management
  • Lead internal and external audits, addressing non-conformities and ensuring timely resolution with CAPA process
  • Streamline incoming parts quality & track metrics.
  • Boundary less involvement in new organizational initiatives.
  • Utilize tools like root cause analysis, Six Sigma, and lean methodologies.
  • Maintain accurate records of quality processes, inspections, and audits.
  • Generate regular reports on quality metrics and performance for senior management.

Qualifications:

  • Bachelor’s degree in a scientific, engineering, or related field. Advanced degree preferred.
  • 8-12 years of experience in Quality Assurance in (relevant industry, e.g., pharmaceuticals, medical devices).
  • Thorough knowledge of relevant regulatory guidelines (e.g., FDA, EMA, ISO standards).
  • Strong organizational skills, with attention to detail and the ability to manage multiple projects simultaneously.
  • Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams.

Preferred Skills:

  • Certification in Quality Assurance.
  • Experience with electronic quality management systems (eQMS).
  • Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

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