Quality Engineer - Medical Device Production & Compliance

Oculus Inc; Lakewood (CO); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Medical, dental, vision

Paid time off

9 holidays + birthday PTO

Life insurance

Disability insurance

401(k) match

Employee assistance program

Costco membership

LifeMart discounts

Company events

Job summary

Oculus Inc in Lakewood, CO is seeking a Quality Engineer, Production, in the medical device field to lead the Quality Management System, ensure regulatory compliance, and drive continuous improvement across manufacturing. You will partner with Operations, Corporate Quality and Production to meet FDA, ISO 13485 requirements, manage audits, CAPA, nonconformances, and data-driven quality initiatives.

Travel up to 5% and passport required.

Qualifications

• Bachelor’s degree in Science, Engineering, or related field preferred.
• 6+ years of experience in quality or engineering within a regulated manufacturing environment.
• Experience in medical device, ophthalmic, or contact lens manufacturing preferred.
• Strong knowledge of FDA cGMP and ISO 13485 quality systems.
• Experience leading audits, CAPA, nonconformance, complaint handling, and document control systems.
• Ability to analyze data and apply statistical methods for quality improvement.
• Excellent written and verbal communication skills.

Responsibilities

• Maintain and improve the local Quality Management System (QMS) in line with FDA cGMP and ISO 13485.
• Design, implement, and improve quality standards, procedures, and practices.
• Ensure document and record control processes including approvals and archival.
• Serve as site SME for regulatory inspections and audits.

Skills

Quality leadership

Regulatory compliance

Statistical methods

Audits & CAPA

Documentation

Data analysis

Education

Bachelor's degree in Science/Engineering

Tools

FDA cGMP

ISO 13485

Change control

Audit management

Job description

Oculus Inc in Lakewood, CO is seeking a Quality Engineer, Production, in the medical device field to lead the Quality Management System, ensure regulatory compliance, and drive continuous improvement across manufacturing. You will partner with Operations, Corporate Quality and Production to meet FDA, ISO 13485 requirements, manage audits, CAPA, nonconformances, and data-driven quality initiatives.

Travel up to 5% and passport required.