Quality System Engineer (Medical Devices)

TL;DR

Quality System Engineer (Medical Devices): Ensuring compliance with global standards and implementing the Quality Management System (QMS) with an accent on FDA, ISO, and EU MDR regulations. Focus on harmonizing quality procedures, conducting gap assessments, and driving continuous improvement across global sites.

Location: Austin

Company

hirify.global is an independent technology consulting firm providing guidance and solutions to businesses across various business lines globally.

What you will do

• Implement and continuously improve the Quality Management System (QMS) to ensure compliance with global medical device regulations.
• Support cross-functional teams in harmonizing and standardizing quality procedures and tools globally.
• Conduct gap assessments of local procedures against corporate standards and applicable regulations.
• Collaborate with R&D, Regulatory, and Operations stakeholders to align local procedures with regulatory requirements.
• Ensure all documentation and processes meet audit and regulatory expectations.

Requirements

• Mandatory experience in the medical device industry.
• Minimum 5+ years of experience in Quality/Regulatory Compliance or a related field.
• Extensive knowledge of 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.
• Proven experience implementing QMS procedures including Design Controls and CAPA.
• Proficiency with Six Sigma, Root Cause Analysis, and FMEA.
• High school diploma required; Bachelor's degree in Engineering preferred.

Nice to have

• Experience with Software as a Medical Device (SaMD) and Class II medical devices.
• Certified Quality Engineer (CQE) or equivalent certification.
• Experience with enterprise quality systems or ERP systems like SAP or EtQ.

Culture & Benefits

• International environment with over 110 different nationalities.
• Strong internal growth culture where many leaders started at entry-level.
• Access to an internal Academy with more than 250 training modules.
• Dynamic atmosphere with regular team-building events and afterworks.

Hiring process

• Brief virtual or phone call to discuss motivations and fit.
• Series of interviews (average of 3) with line managers and team members.
• Case study or technical assessment depending on the specific role requirements.