Quality Assurance Engineer
3B Staffing LLC
Duration: 6 months plus (temp to perm)
Start: ASAP May 27th or June 2nd
Location: NY - fully onsite
Responsibilities
Start: ASAP May 27th or June 2nd
Location: NY - fully onsite
Responsibilities
- Responsible for execution of quality processes and quality systems application within the department and across departments.
- Transfer design to manufacturing and provide feedback and oversight to suppliers to ensure robust quality systems and product
- Drive design improvement, nonconformance and correction action processes internally and with suppliers
- Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues internally and with suppliers
- Provide documentation and respond to requests in internal and external quality inspections
- Manage activities for Risk Management, including development of critical documentation in compliance with Synchron's procedures and external standards
- Assist in developing software manufacturing documentation such as software bill of materials, and software maintenance and release activities.
- Bachelor's degree in biomedical engineering, Electrical Engineering, Software Engineering or other relevant technical or science field.
- 5+ years of experience working with a quality system for Class III FDA-regulated medical devices.
- In-depth knowledge of Design Controls, Quality System Management, Software Systems, Software and Cybersecurity Risk Management, Systems Engineering, and Usability Engineering.
- Have working knowledge of applicable design standards (e.g. IEC 60601-1, IEC 62304, EN ISO 14971, ISO 14708, IEC 62366-1, IEC 62366-2, TIR57, SW96, IEC TR 80002-1)
- Understanding of Quality Systems and applicable GMP regulations and standards (e.g., ISO 13485, QSR 21 CFR Part 820)
- Knowledge of Document Control standards, practices, and principles
- Highly developed written and oral communication skills and ability to work in a team environment
- Possesses initiative and is proactive
- Excellent organizational, time management, and planning skills
- Demonstrated attention to detail and ability to prioritize among multiple projects
Vacancy posted 2 days ago
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