Quality Engineer I - Compliance

About the role

Paragon 28—a Zimmer Biomet company specializing in foot and ankle solutions—is seeking a Quality Engineer I – Compliance to join their team in Englewood, Colorado.

Responsibilities

• Manage CAPA and SCAR systems; execution, monitoring, and managing tasks, balancing multiple priorities while meeting deadlines and quality objectives.
• Perform CAPA investigations as assigned.
• Conduct product evaluations in a timely manner to support complaint investigations; verification of product intended use, product related risk, probable root cause.
• Maintain and analyze department data; perform statistical analysis and identify the need for escalation and/or opportunities for improvement.
• Prepare accurate department reports and present as required.
• Carry out effective resolution when tasked with difficult or unexpected situations in the workplace, as well as complex business challenges.
• Aid in establishing efficient and streamlined processes across the department.
• Accurately represent Paragon processes to internal and external customers.
• Ensure compliance with requirements per the QMS, ISO 13485, FDA QSR, EU MDR and any other applicable regulations or standards.
• Provide support to Quality Department as requested and complete assigned tasks accurately and on time.

Requirements

• Bachelor’s degree and at least 1 year of related experience.
• Familiarity with 21 CFR 820/ISO13485 and other government/ISO standards preferred.
• Experience in regulated industries.
• Medical device experience preferred.
• Strong computer skills (MS Office Suite and Adobe).

Qualifications

• Physical demands: Regular communication, close visual acuity, frequent movement, occasional lifting up to 15 lbs.
• Work environment: Office and warehouse setting.
• Position type: Full-time.
• Travel expectations: Less than 10% overnight travel.

Benefits

Compensation range: $60,000 - $80,000 USD annually based on skills and experience. Eligible for annual bonus.

Pay

$60,000 - $80,000 USD annually based on skills and experience.

Schedule

This is a full-time position with typical business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined with Manager.