Quality Assurance Engineer for EOS imaging, specializing in healthcare solutions. Responsibilities include quality assurance activities aligned with established quality policies and processes.
Responsibilities
Release components and finished products
Product non-conformities and CAPA:
Document the results of non-conformity investigations as NC Owner
Support other departments in resolving product non-conformities as NC Mentor
Supplier management:
Participate in supplier evaluation and monitoring
Ensure the progress and documentation of supplier non-conformities in collaboration with Purchasing
Track improvement actions and supplier non-conformity records
Monitor daily supplier performance; participate in and provide data for the quarterly supplier review
Product documentation:
Assist other departments in the preparation of product documents (production/service file and associated records)
Metrology:
Ensure identification of the company's measuring equipment and their entry in the tooling database
Keep verification or calibration reports and metrology service provider certifications up to date, validate and file them
Promote the Quality approach within the company
Participate in document updates; assist other departments in preparing quality documents
Requirements
Education and experience: Graduate with a master's level (BAC+5) in a general program or in quality; you have initial experience in Quality Assurance in the healthcare industry
Competencies and required skills
Proficiency in English is essential for this position
Mastery of standards: ISO 13485 is required. 21 CFR 820, MDSAP and EU Regulation 2017/745 are desirable.
Excellent interpersonal skills to liaise with all internal and external stakeholders
Strong written accuracy and ability to synthesize are imperative
Autonomy, decision-making ability, and a sense of reporting
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