Cleanroom Quality Control Officer
Job Title
Cleanroom Quality Control Officer
Qualifications Required
Matric
Knowledge, Skills and Experience Required
- Minimum 2 years experience in a production environment
- Experience working within ISO 13485 quality management systems
- Excellent attention to detail
- Strong computer skills (Microsoft Word, Excel, Adobe Acrobat)
- Effective time management skills
- Ability to work independently and as part of a team
Key Roles and Responsibilities
- Operate strictly within the ISO 13485 Quality Management System and work inside Class 7 Cleanroom
- Adhere to company rules, regulations, and quality procedures without deviation
- Ensure all QC work instructions, protocols, forms, and procedures are current and accurate
- Prepare for and participate in audits
- Conduct visual inspections of raw materials, in-process products, and final products
- Perform routine and mechanical testing of raw materials, in-process products, and final products
- Raising and Investigating Non-Conformances whiten the Cleanroom
- Maintain accurate data control and manage mechanical testing records
- Identify and address quality and Product related issues across all processes
- Support R&D with inspections and testing activities
- Carry out reasonable duties as requested by management to support company operations
Critical Responsibility
The Quality Control Officer holds the final authority and accountability for releasing Final Products.
- No balloon catheter may be released without their approval.
- The officer must ensure that 100% of balloon catheters are tested, verified, and compliant with all product specification and regulatory standards.
Apply now!