Senior Quality Assurance Specialist

5 days ago

Thāne, Maharashtra, India beBeeQuality Full time ₹ 21,60,000 - ₹ 26,40,000

Job Title: Quality Assurance Specialist

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About the Role:

We are seeking a detail-oriented Quality Assurance Specialist to join our team. The successful candidate will be responsible for maintaining and updating quality management system documentation, coordinating internal audits, and supporting the training process.

Key Responsibilities:

  • Maintain and update QMS documentation, including SOPs, Work Instructions, and Records.
  • Coordinate internal audits and prepare documentation for external audits.
  • Support the training process by organizing sessions and maintaining training records.
  • Perform basic QC checks and inspections under supervision.
  • Assist with tracking and follow-up on CAPA actions.
  • Maintain supplier documentation and support risk management files.
  • Ensure proper document control and record retention in compliance with ISO 13485.

Qualifications:

  • Degree in Mechanical Engineering or related field.
  • 1-2 years of experience in a quality or manufacturing environment (preferred).
  • Candidate must be from a medical/pharmaceutical background company with hands-on experience in ISO 13485 certification and compliance.
  • Familiarity with medical device regulations is an advantage.

Required Skills:

  • Basic understanding of QMS principles and ISO standards.
  • Good attention to detail and documentation accuracy.
  • Strong organizational and communication skills.
  • Proficient in Microsoft Office (Word, Excel, Outlook).

Benefits:

This role offers opportunities for professional growth and development in a dynamic and innovative environment.

How to Apply:

Applicants should submit their resume and cover letter to [insert contact information].

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