Job Title: Medical Device & Regulations, Camstar (Siemens Opcenter) Lead
Job Summary:
As a Medical Device & Regulations, Camstar (Siemens Opcenter) Lead, you will be responsible for overseeing the implementation and maintenance of Camstar (Siemens Opcenter) software within a medical device manufacturing environment. You will ensure compliance with all relevant regulations and standards to ensure the quality and safety of medical devices produced.
Responsibilities and Duties:
1. Lead the implementation of Camstar (Siemens Opcenter) software within the medical device manufacturing environment.
2. Develop and maintain procedures to ensure compliance with FDA regulations and standards such as ISO 13485.
3. Work closely with cross-functional teams to ensure successful integration of Camstar (Siemens Opcenter) software.
4. Provide training and support to users of the software.
5. Conduct regular audits to ensure compliance with regulations and standards.
6. Continuously improve processes to optimize efficiency and quality.
7. Stay current on the latest regulations and standards in the medical device industry.
Qualifications and Skills:
- Bachelor's degree in a related field
- Minimum of 5 years of experience in medical device manufacturing
- Experience with Camstar (Siemens Opcenter) software
- Strong knowledge of FDA regulations and ISO standards
- Excellent communication and interpersonal skills
- Strong problem-solving abilities
- Ability to work effectively in a team environment
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(Note: This job description is fictional and created for the purpose of this exercise.)