Job Summary

• The Engineering Specialist, Quality supports the product development process, requirement planning and reviews, verification planning, review of test case methods, and defect management and related risk assessments.
• Responsibilities include developing and implementing quality assurance processes for medical devices in compliance with industry standards and regulations, and assuring thorough testing and validation of software and hardware systems.
• The company offers an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Matching Summary

Salary

Base: $160,000 - $170,000; Bonus/Equity: 15% target bonus; Benefits: Comprehensive benefits package including 401(k) with company contributions, paid time off, employee assistance program, and health benefits

Skills & Requirements

Key Requirements

• Bachelor’s degree in Engineering or related field or Associates degree with 15+ years of relevant experience
• Greater than 10 years of related experience in the medical device industry
• Demonstrated knowledge of IEC/ISO 62304 and 21 CFR 820.30
• Experience with FDA regulations and GMPs
• Authorized to work for ANY employer in the United States

Work Rights