Quality Engineer
1 week ago
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).
· Candidate must be from a medical/Pharma background company with hands-on experience in ISO 13485 certification and compliance.
· Familiarity with 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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