Über
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.
Minimum Qualifications
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.
Skills and Knowledge
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
Sprachkenntnisse
- English
Hinweis für Nutzer
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