Quality Assurance Engineer
hace 3 semanas
Operating Company: Nobel Biocare
Location: Barcelona,Cataluña,ES
Date Posted: November 13, 2023
Req Number: R5018089
The Quality Assurance Engineer is accountable for timely execution of quality activities to support production process. The quality assurance specialist supports quality assurance activities for custom-made products.
Accountabilities:
- Responsible for the set-up, maintenance and documentation of QMS (writing and updating SOP and WI related to the manufacturing process)
- Investigates and troubleshoots functionality and performance problems related to production.
- In charge of CAPA related to manufacturing processes.
- Coordination of batch release (tests, internal and external reports, signatures and approvals)
- Variable content generation for lots (UDI, labels)
- Performs testing, sampling and inspection procedures on raw materials, equipment, in-process materials, and/or finished products to ensure that product specifications and company and regulatory requirements are met.
- Support internal and external audits
- Define and implement appropriate quality actions and training
- Coordination of complaint activities related to custom-made product (internal and external reports, gather information from customers/clinicians, guarantee to have signatures and approvals)
- Support for creation or revision of technical documentation with identification of whether input documents fulfil minimum requirements
IND456
LI-EU1
**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**:
- Minimum 2 years experience in the medical device industry or similar in the quality or regulatory sector
**_Envista y sus compañías operativas están comprometidas con la Diversidad, la Inclusión, la Igualdad de Trato y Oportunidades, Igualdad de Género, y con la lucha contra la discriminación en cualquiera de sus formas. Por lo que esta oferta está dirigida a cualquier persona que reúna los requisitos exigidos, independientemente de su condición._**:
LI-EU
**Operating Company**:
Nobel Biocare
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