Quality Engineer I - Compliance
About The Position
Ready to build your career in orthopedic innovation? Paragon 28—a Zimmer Biomet company specializing in foot and ankle solutions—is looking for a Quality Engineer I – Compliance to join our team in Englewood, Colorado. In this impactful role, you’ll help uphold and strengthen our Quality Management System, with a focus on Corrective and Preventive Actions (CAPA) and Supplier CAPA processes. You’ll play a key part in ensuring product quality and regulatory compliance by investigating medical device complaints, supporting product evaluations, and analyzing system performance. This is an excellent opportunity for someone who thrives on problem-solving, values precision, and wants to contribute to the continuous improvement of life-changing medical technologies. This is an onsite position with some remote work flexibility.
Requirements
- Bachelor’s degree and at least 1 year of related experience.
- Strong computer skills (MS Office Suite and Adobe).
Nice To Haves
- Familiarity with 21 CFR 820/ISO13485 and other government/ISO standards preferred.
- Experience in regulated industries.
- Medical device experience preferred.
Responsibilities
- Manage CAPA and SCAR systems; Execution, monitoring and managing tasks, and balance 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.
- Assist 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.
- Other duties as assigned.
Benefits
- Eligible for annual bonus.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
