What are the responsibilities and job description for the Quality Assurance Engineer position at Aneuvo?
We are looking for a full-time quality assurance engineer with medical device experience. This position offers a unique opportunity to implement and improve a developing quality management system while working directly with a multidisciplinary team to bring high-quality, innovative products from concept to commercialization. The ideal candidate has experience / training with medical device quality requirements, including 21 CFR 820 and ISO 13485. Most importantly, candidates must be ready to put their skills, organization, attention to detail, and knowledge to use in developing medical devices that will define the future of medicine and benefit people around the world.
Responsibilities :
- Implement existing standard operating procedures (SOPs) and establish new or improved procedures to balance quick innovation with strong quality practices
- Assist in medical product and process verification and validation activities
- Assist in medical device design & development and risk management activities
- Identify applicable international and / or FDA-recognized consensus standards, maintain a standards library, and coordinate with R&D team to ensure requirements are met
- Manage purchasing and receiving processes
- Manage supplier evaluation, approval, and auditing program
- Coordinate inventory management with R&D team
- Conduct internal audits
- Identify and execute nonconformities and corrective / preventive actions (CAPAs)
- Develop the general Quality Management System to meet ISO 13485 requirements
Qualifications :
What we offer :
Last but not least, we are a small team and thus everyone plays a critical role - your voice will be heard clearly and loudly! Come join us and build the future, today.
