Principal Quality Systems Engineer

About the Company

A innovative medical device company focused on the design manufacture and distribution of sterile catheter-based software-enabled and electromechanical medical devices is seeking an experienced Quality Engineer to join their team. This is a hands-on role within a small collaborative environment where team members wear multiple hats and quality is embedded into every aspect of the organization.

Position Overview

This role provides Quality Engineering support across operations while helping oversee the companys Quality Management System. Working closely with a lean multidisciplinary team the Quality Engineer will ensure ongoing compliance with FDA QMSR requirements and ISO 13485 standards while driving continuous improvement across all quality functions from document control and CAPA to supplier quality and post-market surveillance.

Key Responsibilities

Quality Management System

• Help maintain and continuously improve a QMSR and ISO 13485-compliant QMS
• Support development and revision of SOPs work instructions forms test protocols and other controlled documents
• Manage document control and records management in accordance with 21 CFR Part 820
• Participate in internal audits and support external audits including FDA and supplier audits
• Lead or support CAPA investigations including root cause analysis timely closure and effectiveness verification
• Develop quality metrics and data analysis to guide risk-based decision making

Operations & Supplier Quality

• Partner with Operations to ensure manufacturing processes are appropriately controlled and validated
• Contribute to risk management activities sterilization validation and data integrity practices
• Support incoming inspection nonconforming material control and product disposition
• Provide Quality Engineering input on infrastructure and facility expansion projects
• Support supplier qualification ongoing evaluation and performance monitoring
• Help conduct supplier audits and review corrective action responses

Post-Market Surveillance

• Support complaint handling MDR reporting and trend analysis activities
• Stay current on relevant regulatory standards and help keep the broader team informed of changes
• Assist with preparation for FDA inspections and Notified Body audits

Leadership & Culture

• Champion a proactive quality culture across a small cross-functional team
• Provide quality training and mentorship to colleagues as needed

Qualifications

Required:

• Bachelors degree in Engineering Life Sciences or a related technical field
• 5 years of quality systems experience within a medical device manufacturing organization
• Proven track record implementing evolving and improving QMS programs compliant with FDA 21 CFR Part 820 ISO 13485:2016 and ISO 14971
• Demonstrated end-to-end QMS ownership including CAPA document control complaint handling internal auditing and supplier quality
• Strong technical writing skills with the ability to produce clear compliant documentation
• Experience with statistical techniques sampling plans and data analysis for validation and process capability studies
• Comfortable working in a small company environment where adaptability and initiative are essential

Equal Opportunity Statement

This employer is committed to building a diverse and inclusive workplace. All qualified applicants will be considered without regard to race color religion sex sexual orientation gender identity national origin age disability veteran status or any other characteristic protected under applicable federal state or local law.