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Medical Device Validation Specialist
vor 1 Monat
We are seeking a highly skilled Medical Device Validation Specialist to join our team at Michael Page.
About the Role:This is an exciting opportunity to work with a leading company in the medical device industry, where you will be responsible for ensuring the transfer of new products and technologies from R&D to manufacturing.
You will work closely with cross-functional teams to facilitate technology transfer, provide expertise on scalability and process capability, and troubleshoot potential issues during the transfer process.
Additionally, you will play a key role in resolving non-conformities related to products, participating in supplier audits, and serving as the single point of contact for contract manufacturing organizations.
Responsibilities:- Transfer of design into production: Work closely with various departments and contract manufacturing organization to ensure smooth transition.
- Implementation of documentation: Major stakeholder in ensuring accurate documentation to support transfer stages.
- Training of production teams: Participate in training sessions to ensure effective transfer of design into production.
You will also be responsible for qualification and validation of equipment and processes, including defining and implementing process validation plans, coordinating and supervising process validation activities, and controlling implementation of all qualification and validation activities.
Requirements:To succeed in this role, you will need:
- Degree in Medical Technology, Engineering, or related field.
- Fluency in English.
- First experience in industrialization and validation within the Medical Device industry.
- Good understanding of highly regulated environments.
- Strong knowledge of ISO 17665-1, ISO 13485, and ISO 14971.
- Excellent computer skills.
In return, you can expect a competitive salary of approximately $120,000 per year, depending on location and experience.
About Us:Moving to a new career can be daunting. Our mission at Michael Page is to help professionals find fulfilling careers that meet their aspirations. If you're looking for a challenging and rewarding role, we encourage you to apply.