Quality Assurance Engineer

Job Description:

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

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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:
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.

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Operating Company: Nobel Biocare

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envistas internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
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Fecha de publicación: 15/11/2023