Provide Quality Engineering support for Product Development Projects throughout all phases of Design Controls (Concept to Launch), with additional responsibility 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 particular focus on Design Controls.

DUTIES AND RESPONSIBILITIES

  • 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

  • Lead post-market surveillance activities for commercially released product (complaint management includingMDR reporting)

QUALIFICATIONS

  • BS in Sciences, or Engineering field

  • 5+ years hands on medical device manufacturing (OEM) experience.

  • Working knowledge of 21 CFR 820 and ISO 14971:2019 are a must; Working knowledge of ISO 13485:2016 is desired

  • 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

 

About Access Vascular

Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and are capable of long-term thrombus resistance and infection protection.

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