Quality Assurance Engineer

Duration: 6 months plus (temp to perm)

Start: ASAP May 27 th or June 2 nd

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