JOB DESCRIPTION

Provide Quality Engineering support for Product Development Projects throughout all phases of Design Controls (Concept to Launch), with additional responsibility for post-market surveillance activities. This is a collaborative position working closely with R&D, Manufacturing, Sales & Marketing, and others to ensure compliance with AVI’s QMS, and FDA QSR requirements, with a particular focus on Design Controls.

QUALIFICATIONS

• BS in related technical field, preferably Engineering
• 3-5 years of design assurance experience in the Life Science or Medical Device Industries
• Working knowledge of 21 CFR 820 and ISO 14971:2019 are a must
• Working knowledge of data analysis methods, including basic statistics, preferably using Minitab or other similar data analysis software
• Teamwork, flexibility and adaptability to change
• Critical reasoning and excellent data presentation skills
• Excellent written and verbal communication and skills
• Self-initiator with strong organization skills
• Ability to lead through influence

• Fulfill a Design Assurance (DA) role on Product Development projects
• Lead cross-functional teams to implement risk assessment (FMEAs) and risk management processes (RMP / RMR / RMF)
• Support development, implementation, and maintenance of Design Verification & Validation (V&V) methodologies and best practices to impact product quality and launch timeliness
• Interface with manufacturing, NPI Engineering, Research and Development, and other Quality team members to ensure effective design transfer to manufacturing