Quality Engineer
$85,000–$95,000 year
On-siteArvada, Colorado, United States
Job Summary
Execute quality engineering activities for product design and manufacture in compliance with Quality Management System and international regulations. Collect and analyze data to evaluate non-conforming products, lead investigations into component failures, and generate risk assessments for distributed goods. Lead CAPA projects, review change impact assessments, and manage external manufacturer non-conformities while establishing quality control inspection plans. Perform daily complaint handling, conduct customer-related process evaluations, and drive production area improvement plans. Requires 1-3 years of Class II/III medical device experience, knowledge of FDA and ISO 13485, and proficiency with quality tools. Salary range $85,000-$95,000 with annual bonus; occasional travel required.
Required Qualifications
- Minimum related work experience of 1-3 years in Class II/III medical device manufacturing or related regulatory industry
- Knowledge of regulatory requirements (e.g., FDA, ISO 13485) as required for the position
- Must have proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning
- Ability to analyze and problem-solve with CAPA experience
- Ability to work within a changing environment
- Ability to work with a wide variety of personnel on all levels and utilize constructive confrontation
- Must be able to work in a clean room environment and tolerate chemical odors
- Must be able to work in a lab environment and tolerate the smell and sight of blood
- Must be willing to take on related duties as required in support of company and departmental objectives
- Bachelor's Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, and Biology)
- Sitting 60-80%, standing & walking 20-40%
- Repetitive work on computer 80%
- Oral and written comprehension
- Must be able to communicate across functional lines
Desired Qualifications
- Experience with MDSAP and Medical Device Requirements is a plus
- ASQ Certified Quality Engineer or other ASQ Certifications is a plus
- Excellent communication (written and verbal) and presentation skills
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.