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Manufacturing Engineer
hace 3 semanas
**Your purpose on the role**:The Manufacturing Engineer ensures that compliance of suppliers, the incoming materials and the equipment at Mimetis are maintained according to the QMS requirements and the other relevant regulations. This includes procurement activities, identifying new suppliers of materials and services and designing test protocols. Setting up validation processes, infrastructure maintenance and ensuring of cleanroom compliance are processes owned by this function as well.
**Main accountabilities**:
- Clean room maintenance and microbiological testing regime
- Overseeing the procurement of raw materials and services necessary for the manufacture of bone graft and 3D products: demand planning, sending the manufactured products to sterilization and packaging provider, as well as to quality control provider.
- Maintenance of stock, distribution process and process related documentation
- Creation and updates of supply chain-related SOPs, Work instructions, and Forms.
- Procurement and supply chain related support during audits
- Establish test plans for outsourced validation activities and integrate output into quality management system
- Support in manufacturing activities
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**Job Requirements**:
**Critical Knowledge and Qualifications**:
- Master or comparable academic degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Chemistry, Pharmacy, Natural Science or equivalent
- Relevant experience with development projects executed in a regulated medical device environment according to standards and regulations such as ISO 13485, ISO 14971, 21 CFR part 820, MDSAP, MDR, etc.
- Current knowledge of mechanical engineering.
**Critical Skills/technical know-how**:
- Current knowledge of risk analysis in accordance with ISO 14971, or other relevant standards/regulations.
- Current knowledge of process engineering and materials science
- Fluent in Spanish and English, both in conversation as well as in writing
**Critical Experience**:
- Minimum 3 years experience in medical device industry, or similar
- Experience with packaging development, supply chains or cleanroom maintenance including all relevant qualification/validation activities.
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**Operating Company**:
Nobel Biocare
**About Envista**:
Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists’ clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including KaVo, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.
