Manufacturing Engineer

Operating Company: Nobel Biocare Location: Barcelona, Cataluña, ES Date Posted: July 24, 2024 Req Number: R5020428



Job Description:
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 quality management system 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 the quality management system
Support in manufacturing activities

Job Requirements:
Critical Knowledge and Qualifications:

Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Chemistry, Pharmacy, Natural Science or higher technician.
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.

Critical Skills/technical know-how:

Current knowledge of process engineering
Fluent in Spanish and English, both in conversation as well as in writing. Catalan desired
Current knowledge of risk analysis in accordance with ISO 14971, or other relevant standards/regulations.

Critical Experience:

Minimum 2 years experience in the medical device industry, or similar
Experience with supply chain and cleanroom maintenance including all relevant qualification/validation activities (IQ, OQ, PQ of equipment and validation processes).


#J-18808-Ljbffr