Software Quality Engineer/W2 ONLY

About the job

Qualifications:

• Bachelor’s Degree in a scientific or technical discipline preferred or 10+ years of experience in a related field.

• 1+ year in a regulated environment, preferably in medical devices with knowledge of quality system processes.

• Experience in applying quality regulations and standards {e.g., 21CFR 820, ISO 13485, ISO 14971, IEC62304, Cybersecurity- ISO 27001), and working knowledge of current and applicable GMP regulations is required.

• Experience in reviewing, and executing validation and change control documents, authoring SOPs, Protocols {IQ, OQ, PQ) of Process Control Systems

• Demonstrates project management skills