Quality Engineer -Implementing ISO 13485

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