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