Quality Engineer - Compliance

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 onsite position with some remote work flexibility.

• 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.

• Bachelor’s degree and at least 1 year of related experience.

• Familiarity with 21 CFR 820/ISO
  13485 and other government/ISO standards preferred.

• Experience in regulated industries.

• Medical device experience preferred.

• Strong computer skills (MS Office Suite and Adobe).

• This job operates in an office and warehouse environment. This role routinely uses standard office equipment such as computers, phones and copy machines.

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is regularly required to communicate with individuals internal and external to the organization. The employee is required to have close visual acuity to perform activities such as inspecting small parts, viewing computer terminal and reviewing reports. The employee frequently is required to move about the facility. The employee may be required to lift up-to 15 lbs.
  
  by themselves.

• 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.

Less than 10% overnight travel.

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

EOE