Quality Engineer I

TL;DR

Quality Engineer I (Medtech): Develops, modifies, applies and maintains quality standards, processes and procedures within Quality Management Systems for medical device software with an accent on software design controls, defect resolution, NC/CAPA and complaint investigations. Focus on ensuring compliance, supporting clinic team software development and driving continuous improvement in regulated environment.

Onsite Lafayette, Colorado, United States. Unrestricted U.S. work authorization required at time of hire; no sponsorship for this level.

Salary: $64,800 - $97,200 USD

Company

Global leader in healthcare technology advancing surgical care for spine and cranial conditions through implants, navigation, robotics, imaging and planning tools.

What you will do

• Develop, modify and maintain quality standards, processes and procedures within Quality Management Systems.
• Collaborate across functions to uphold product quality, review software design controls deliverables including requirements, specifications, verification and validation.
• Triage issues, support defect resolution and ensure corrective measures meet standards.
• Support NC/CAPA processes including initiation, investigation, root cause analysis and effectiveness checks.
• Maintain quality documentation for medical and nonmedical device software supporting clinic team.
• Perform complaint investigations, drive defect management and continuous improvement.

Requirements

• Bachelor's degree in a technical related field.
• Ensure accuracy, completeness and adherence to Quality System Requirements.
• Support document control activities within Quality Management System.
• U.S. work authorization required; no sponsorship (H-1B, etc.) for roles below Principal level.

Nice to have

• Engineering degree.
• 1-4 years of industry experience.
• Medical device experience.
• Software knowledge, Design Quality Engineering, NC/CAPA, defect resolution.
• Experience in regulated industry or healthcare.

Culture & Benefits

• Onsite 4 days a week to drive performance and collaboration.
• Competitive salary, hirify.global Incentive Plan (MIP).
• Health, dental, vision insurance; HSA, FSA; life insurance, LTD.
• 401(k) with employer match, PTO, paid holidays, tuition reimbursement.
• Employee Stock Purchase Plan, EAP, global well-being program.