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Quality Assistant -Implementing ISO 13485

2 years

0 Lacs

thane maharashtra

Posted:6 days ago| Platform: SimplyHired logo

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Skills Required

microsoft word microsoft excel microsoft outlook microsoft office bachelor's degree in-person manufacturing diploma communication skills

Work Mode

On-site

Job Type

Full Time

Job Description

Job Description for a QC Assistant*
  • Key Responsibilities: *
  • Assist in maintaining and updating QMS documentation (SOPs, Work Instructions, Records).
  • Help 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.
  • Help maintain supplier documentation and support risk management files.
  • Ensure proper document control and record retention in compliance with ISO 13485.
  • Promote awareness of quality procedures across departments.
**Qualifications & Experience: **
  • Diploma or Bachelor s in Mechanical, Engineering, or related field.
  • 1–2 years of experience in a quality or manufacturing environment (preferred).
  • Familiarity with ISO 13485 and medical device regulations is an advantage.
Skills Required:
  • 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).
  • Ability to follow procedures and work collaboratively in a team.
Job Type: Full-time
Work Location: In person

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