Senior Quality Engineer

Roles & Responsibilities

• Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness.
• Own multiple subassemblies for a surgical robotics platform, ensuring design integrity, quality, and manufacturability.
• Investigate non-conformances (NCs) using root cause analysis and drive CAPA within the QMS framework.
• Develop and maintain FMEAs, support risk mitigation, and lead manufacturing issue resolution and qualifications (IQ/OQ/PQ).
• Identify and implement compliant, alternative solutions to engineering and production challenges while driving continuous improvement.
• Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirements.
• Collaborate with cross functional teams to deliver quality compliant outcomes.
• Interpret and apply medical device regulations and standards to projects and processes.
• Support audits and regulatory inspections, ensuring timely closure of actions.

Qualifications

• BACHELOR OF COMPUTER SCIENCE

Pay

Salary Range: $120,000- $140,000 a year

Benefits

TCS Employee Benefits Summary

• Discretionary Annual Incentive.
• Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
• Family Support: Maternal & Parental Leaves.
• Insurance Options: Auto & Home Insurance, Identity Theft Protection.
• Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
• Time Off: Vacation, Time Off, Sick Leave & Holidays.
• Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.