
Sterility Assurance Engineer
Are you passionate about ensuring the safety and quality of medical devices? Are you detail-oriented and experienced in sterility assurance? Then we have a career opportunity for you! At Philips, we are seeking a skilled Sterility Assurance Engineer to join our team. As a Sterility Assurance Engineer, you will play a critical role in ensuring the sterility of our medical devices, ultimately contributing to the well-being of patients worldwide. We are looking for a highly motivated individual with a strong background in sterility assurance and a keen eye for detail. Join us in our mission to improve people's lives through meaningful innovation and apply for the Sterility Assurance Engineer position at Philips today.
- Develop and maintain sterility assurance protocols and procedures in compliance with applicable regulations and standards.
- Perform sterility validation studies and ensure that all testing is conducted accurately and meets established criteria.
- Conduct risk assessments and implement appropriate corrective and preventative actions to mitigate potential sterility risks.
- Collaborate with cross-functional teams to ensure the sterility of medical devices throughout the entire product lifecycle.
- Monitor and analyze data to identify trends and areas for improvement in the sterility assurance process.
- Stay up-to-date on industry trends and changes in regulations related to sterility assurance.
- Conduct internal and external audits to ensure compliance with sterility assurance requirements.
- Train and mentor team members on sterility assurance principles and procedures.
- Investigate and address any sterility-related issues or non-conformities.
- Communicate effectively with stakeholders, including regulatory agencies and internal teams, regarding sterility assurance matters.
- Continuously strive for process improvement and implement best practices to enhance the sterility assurance process.
Bachelor's Degree In Biomedical Engineering, Microbiology, Or Related Field
Minimum Of 3 Years Experience In Sterilization Process Validation And Microbiological Testing
Knowledge Of International Standards And Regulations Related To Sterilization, Such As Iso 11135 And Fda Guidelines
Experience In Implementing And Maintaining Sterilization Processes In A Medical Device Manufacturing Environment
Strong Analytical And Problem-Solving Skills, With The Ability To Troubleshoot And Resolve Issues Related To Sterility Assurance.
Risk Management
Quality Assurance
Process Improvement
statistical analysis
Root Cause Analysis
Regulatory compliance
aseptic techniques
Microbiology Expertise
Sterile Packaging
Sterilization Validation
Communication
Conflict Resolution
Customer Service
Leadership
Time management
creativity
flexibility
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Sterility Assurance Engineer in Colorado Springs, CO, USA is $76,000 - $120,000 per year. This can vary depending on factors such as experience, education, and the specific company or industry.
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Royal Philips is a health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care.

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