Senior Quality Engineer - Design Control & Risk

Highridge Medical LLC; Westminster (CO); On-site; USD 80,000 - 100,000; Full time

Job summary

Highridge Medical LLC is seeking a Sr Quality Engineer to ensure compliance with design control processes and standards for new product development. The role includes leading quality projects, risk management activities, and collaborating effectively across departments.

The ideal candidate will have a B.S. in engineering or equivalent, and certification as a quality engineer, along with 4-6 years of relevant experience. Join us in our commitment to improving spine care through innovation.

Qualifications

• Ability to work in a team environment and build relationships.
• Experience with compliance to design control processes.
• Able to interpret engineering drawings and GD&T principles.

Responsibilities

• Serve as the design quality representative on engineering teams.
• Guide planning and documentation of design control activities.
• Lead quality related problem solving, issue investigation, and data analysis.

Skills

Team collaboration

Quality engineering project facilitation

Effective communication

Statistical analysis

Education

B.S. in engineering or related field

Certification as a quality engineer (e.g., CQE)

Tools

ISO 13485

ISO 14971

FDA and EU medical device regulations

Job description

Highridge Medical LLC is seeking a Sr Quality Engineer to ensure compliance with design control processes and standards for new product development. The role includes leading quality projects, risk management activities, and collaborating effectively across departments.

The ideal candidate will have a B.S. in engineering or equivalent, and certification as a quality engineer, along with 4-6 years of relevant experience. Join us in our commitment to improving spine care through innovation.