DirecciónDescription
The Junior Quality Assurance Technician is accountable for a timely execution of quality activities to support production process.
This role is to cover a vacancy at Mimetis Biomaterials (), a small medical device company located in Barcelona which is part of Nobel Biocare.
Accountabilities :
Support for the set-up, maintenance, and documentation of QMS (writing and updating SOP and WI related to the manufacturing process)
Support for investigating and troubleshooting functionality and performance problems related to production.
Support of CAPA related to manufacturing processes.
Coordination of batch release (tests, internal and external reports, signatures and approvals)
Perform data analysis and documentation of quality controls on raw materials, equipment, in-process materials, and / or finished products to ensure that product specifications and company and regulatory requirements are met.
Support for defining and implementing appropriate quality actions and training
Support for creation or revision of technical documentation with identification of whether input documents fulfil minimum requirements
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Job Requirements :
Critical Knowledge and Qualifications :
Degree in Material Science Engineering, Biomedical Engineering, Industrial Engineering, Mechanical 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.
Critical Skills / technical Know-how :
Current knowledge of medical device standards
Current knowledge of process engineering and materials science
Fluent in Spanish and English, both in conversation as well as in writing
Able to communicate effectively with team members
Critical Experience :
From 1 to 2 years’ experience in the medical device industry or similar in the quality or regulatory sector
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Operating Company : Nobel Biocare
Nobel Biocare
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