Quality Systems Engineer

Duration: 5+ months | Location: Austin, TX (Hybrid – 3-4 days onsite)

About the role

Every Turnberry consultant belongs to a practice, an internal group of consultants and leaders with shared experience and expertise. Each of these practices aligns to one of the core services Turnberry offers to clients. As a Quality Systems Engineer, you will join Turnberry's Digital Modernization practice, where technology and strategy combine to deliver exceptional digital experiences, empowering organizations to thrive in today's digital market.

Responsibilities

• Ensure compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS)
• Support the global development, implementation, and continuous improvement and harmonization of the local Quality Management System (QMS) in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, and EU MDR as well as corporate procedures and requirements
• Support cross-functional teams in the harmonization and standardization of quality procedures, tools, and best practices across sites and regions
• Complete gap assessments for local procedures against corporate procedures, requirements, and applicable medical device regulations and standards
• Collaborate with cross-functional team members to align and execute updates to local procedures to align with applicable requirements

Requirements

• High school diploma or equivalent required
• Bachelor’s degree in Engineering preferred
• Technical, engineering, and/or scientific background is strongly preferred
• Minimum 5+ years of experience in Quality/Regulatory Compliance or related field required
• Must have previous Medical Device Experience
• CQE or equivalent certification preferred
• Extensive knowledge of global regulatory requirements for medical devices, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971
• Skilled in developing and implementing procedures for various QMS elements including but not limited to purchasing controls, design controls, nonconformance management, validation, and corrective and preventive actions (CAPA)
• Familiarity with quality tools and methodologies (e.g., Six Sigma, root cause analysis, risk management, SPC, FMEA)
• Strong communication and collaboration skills, with the ability to influence and drive alignment across diverse stakeholders (R&D and Regulatory)
• Must be familiar with Microsoft Office Suite
• Preferred experience with enterprise quality systems and ERP systems (e.g., SAP, EtQ)
• Preferred experience with SaMD (Software as a medical device) and class II medical devices

Pay

The salary range for this role is $70,000 to $100,000 or the hourly equivalent. Pay is based on several factors including but not limited to education, work experience, and certifications.

Benefits

• Comprehensive healthcare package (medical, dental, vision)
• Disability and group term life insurance
• Health and flexible spending accounts
• Utilization bonus
• 401(k) with match
• Flexible time off for salaried employees
• Parental leave for salaried employees
• Flexible work arrangements (all benefits are subject to eligibility requirements)