Penetration Tester developing security solutions at Fidelity Investments. Collaborating on impactful projects across cybersecurity and automation.
About the role
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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