Cleanroom Quality Control Officer

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Job Title

Cleanroom Quality Control Officer
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Qualifications Required

Matric

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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
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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
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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.
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