Principal Quality Engineer (MedTech)

TL;DR

Principal Quality Engineer (MedTech): Providing technical leadership for quality assurance across new product development and sustaining engineering programs with an accent on regulatory compliance and risk management. Focus on driving product quality, leading complex CAPA investigations, and ensuring adherence to FDA and ISO standards throughout the product lifecycle.

Location: Must be based in Austin, Texas (Onsite)

Company

hirify.global is an innovation-driven medical technology company dedicated to developing clinically differentiated solutions that improve patient outcomes and transform healthcare workflows.

What you will do

• Serve as the senior QA representative for new product development and sustaining engineering projects.
• Lead design and manufacturing reviews to ensure compliance with QMS and regulatory standards.
• Manage risk activities including DFMEAs, PFMEAs, and ISO 14971 documentation.
• Lead complex CAPA investigations, root cause analyses, and effectiveness verification.
• Provide technical leadership during internal, external, and regulatory audits including FDA and ISO 13485.
• Mentor junior QA engineers and influence cross-functional teams on quality best practices.

Requirements

• Must have full-time work authorization in the United States without sponsorship.
• Bachelor's degree in Biomedical, Mechanical, or Manufacturing Engineering.
• 5+ years of Quality Assurance experience in medical devices or highly regulated industries.
• Strong knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.
• Experience with design controls, process validation, and software verification and validation.
• Ability to work onsite in Austin, Texas.

Nice to have

• ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt.
• Experience with PLM and ERP systems like Agile, Oracle, SAP, or Windchill.
• Background in software as a medical device (SaMD).

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan.
• Vacation, sick leave, and paid holidays.
• Income protection plans and legal services.
• Collaborative environment focused on scientific excellence and patient outcomes.