Quality Engineer I - Compliance at Zimmer Biomet in Englewood, CO

Summary: Zimmer Biomet is a global medical technology leader dedicated to enhancing patient mobility. They are seeking a Quality Engineer I – Compliance to help uphold and strengthen their Quality Management System, focusing on CAPA processes and ensuring product quality and regulatory compliance.

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

Required Qualifications:
- Bachelor's degree and at least 1 year of related experience
- 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

Preferred Qualifications:
- 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)

Required Skills: Corrective and Preventive Actions (CAPA), Supplier CAPA, Medical device complaint investigation, Product evaluation, Statistical analysis, Quality Management System (QMS), ISO 13485, FDA Quality System Regulation (QSR), EU Medical Device Regulation (EU MDR), 21 CFR 820, Microsoft Office Suite, Adobe, Precision

Benefits: Eligible for annual bonus, Development opportunities, Robust employee resource groups (ERGs), A flexible working environment, Location specific competitive total rewards, Wellness incentives, A culture of recognition and performance awards