Qualification Required

• Degree in Microbiology / Biomedical / Mechanical

Roles And Responsibilities

• Experience in Medical device manufacturing industry.
• Create/update cleaning process validation protocol/report.
• Create/update cleaning process work instruction.
• Experience in Sterilization and chemical residue identification/Acceptance criteria determination.
• Work independently with the internal and external stakeholders for execution.
• Candidate must be detail oriented, to review documents with specific (Company/external standards) requirements.
• Navigates complex government regulations to include FDA & QSR requirements and guidance under 21 CFR820, ISO13485 and ISO14971.
• Present technical data to groups within and outside the organization.

Required Technical And Professional Expertise:

Cleaning validation (Sterilization, chemical residue), 21 CFR820, ISO13485 and ISO14971, Medical Device Quality Management system