Software Quality Sr Engineer Job at Zimmer Biomet, Austin, TX

  • Zimmer Biomet
  • Austin, TX

Job Description

Zimmer Biomet seeks a senior software quality engineer to oversee validation, compliance, and quality assurance activities for medical device software in regulated environments. The remote role involves reviewing requirements and deliverables against FDA, ISO, and IEC standards, supporting the full software development lifecycle.

Responsibilities

  • Perform software quality review of requirements, design, and deliverables for regulatory compliance
  • Review and approve requirement specifications, test plans, validation protocols, and traceability matrices
  • Develop and execute test cases and validation protocols for embedded and cloud-based systems
  • Support defect investigations, root cause analysis, and risk assessment activities
  • Ensure end-to-end traceability between requirements, risk controls, and verification evidence

Requirements

  • Bachelor's degree in computer science, engineering, or related field
  • 4+ years software validation and quality experience in regulated environments
  • Knowledge of FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11
  • Experience with validation deliverables: test plans, protocols, RTM, and reports
  • Familiarity with risk management processes and ISO 14971 standards
  • Experience in design reviews, code reviews, and quality reviews

Compensation: $100,000 - $124,000 USD / Annual

Job Tags

Remote work

Similar Jobs

RK Mechanical, Inc.

Shop Pipe Welder - TIG Job at RK Mechanical, Inc.

 ...Description The Shop Pipe Welder is a highly skilled member of our fabrication team, responsible for producing precise, high-quality...  ...Other Duties as assigned. Qualifications ~5 years of experience, 3 years welding experience minimum preferred. ~ Familiarity... 

HHDC

Chief Engineer (Union) - Live In Job at HHDC

SUMMARYThe Chief Engineer - Live In is a union-represented maintenance leadership position responsible for overseeing property maintenance...  ...schedules.* Perform and oversee plumbing, electrical, HVAC, carpentry, painting, appliance, and general property repairs.... 

Northside Hospital Inc.

Oncology Clinical Data Specialist Job at Northside Hospital Inc.

 ...: ADMINISTRATIVE ASSISTANT Join a growing team focused on empowering individuals to make their own health care choices and live independent lives. Palco employs over 100 people from 22 states and partners with governments and state agencies to provide various self... 

Morgan County Government

Environmental Health Specialist - Foods/Food Inspector Job at Morgan County Government

 ...for remodeling or additions, educating managers and owners, and holding training sessions...  ...and Police and Fire departments to ensure safety of the public/citizens. Inspects...  ...plans. Enforces rabies laws, including transporting animal samples to ISDH laboratories as needed... 

Ansible Government Solutions

Optician Job at Ansible Government Solutions

 ...Overview Ansible Government Solutions, LLC (Ansible) is currently seeking Opticiansto support operations at the San Francisco VA Medical Center located at 4150 Clement St, San Francisco, CA 94121. The schedule is typically Monday-Friday, 8am-4:30pm. If you accept employment...