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Quality Engineer (Cleaning Validation)
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
報酬と福利厚生
A candidate’s pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.