Senior Quality Assurance Engineer

Comrise; Kansas City (KS); Hybrid; USD 70,000 - 90,000; Full time

Job summary

A leading company in medical device technology is seeking a hybrid R&D and Quality Engineer to join their innovative team in Kansas City. You will work collaboratively to ensure effective implementation of cutting-edge technology, helping improve patient outcomes worldwide while working in a fast-paced environment. This role requires a Bachelor’s in engineering and relevant experience in R&D and quality assurance to drive success in product development.

Qualifications

• Bachelor's degree in engineering is required.
• At least 2 years of engineering experience.
• Experience with design verification and validation preferred.

Responsibilities

• Ensure implementation of technology for medical devices is compliant and effective.
• Collaborate with R&D, Marketing, and Regulatory Affairs teams.
• Combine responsibilities of R&D Engineer and Quality Engineer.

Skills

Technical engineering expertise

Statistical analysis

Proficiency in ISO 13485 standards

Design verification

Validation processes

Research & Development engineering

Education

Bachelor's degree in engineering

Mechanical, Electrical, Bioengineering, Materials Science or related fields

Job description

You will be a key member of the new product development team, ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with industry practices.

Working closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs teams, you will operate in a fast-paced environment with opportunities to contribute to the success of the company and improve patient outcomes worldwide.

This position is a hybrid role, combining responsibilities of a traditional R&D Engineer and a Quality Engineer.

Candidate must reside within a commutable distance to Tempe, AZ, and be onsite at least 3 days per week; this role is not fully remote.

Required Qualifications:

• Bachelor's degree in engineering, preferably in Mechanical, Electrical, Bioengineering, Materials Science, or related fields
• At least 2 years of engineering experience
• Experience in R&D and Quality engineering preferred
• Technical engineering expertise essential
• Experience with design verification and statistical analysis required
• Research & Development engineering background preferred
• Proficiency in basic statistics analysis
• Experience with design verification & validation
• Knowledge of standard medical device regulations
• Familiarity with ISO 13485 and 14971 standards

Experience in the Medical Devices industry is preferred but not mandatory.