Senior Quality Assurance Engineer

Responsible for operational quality input and deliverables for manufacturing programs throughout the product lifecycle, supporting development activities and ensuring compliance with quality systems and regulations.

Requirements

• Bachelor's Degree (BS) in life science discipline or equivalent combination of education and experience.
• 5+ years of experience in medical device development, or 3+ years of experience in a Design Assurance or Quality Engineering role
• Experience working in quality systems as defined in 21 CFR 820 and ISO 13485.
• Development project team member on complex medical device development programs, including systems
• Understanding of ISO 14971 and application of risk management to product development and processes.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• MN Paid Leave
• Short-Term & Long-Term Disability