Responsibilities
- Lead and improve lot review and release processes within Finished Goods Operations.
- Drive continuous improvement initiatives across inspection and acceptance activities, expanding beyond Finished Goods.
- Provide quality expertise and support across functions, including NC/CAPA ownership and resolution.
- Ensure compliance with sterility standards through oversight of environmental monitoring, utilities, and sterilization processes (EtO, radiation).
- Review and validate cleaning and sterilization protocols in line with ISO standards.
- Analyze sampling and monitoring data using statistical techniques to identify trends and trigger actions.
- Act as microbiology technical lead in cross-functional teams, supporting product and process issues.
- Support external audits (FDA, IMB, BSI) and contribute to procedure development and training.
Requirements
- Bachelor’s degree in Science, Engineering, or a related field
- 0+ years of experience
Nice to Have
- Experience in working in a compliance risk situation.
- Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)
- Previous experience with ERP systems (SAP, Oracle etc,)
Additional Information
- Travel Percentage: 10%
- Equal opportunity employer: race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status
- Non-disclosure of compensation information by employees with access unless under specific legal or investigative circumstances
