Job Summary

• The Process Quality Engineer ensures facility and product compliance with ISO 13485 and all relevant regulations, standards, and procedures.
• This role involves optimizing production by creating and executing accurate documentation, documenting nonconformances, and supporting continuous improvement activities.
• The position offers the opportunity to work closely with other Quality, Manufacturing, and Design Engineers on innovative MRI system magnet designs.

Matching Summary

Salary

Base: $87,000 to $139,200; Bonus/Equity: Annual incentive bonus, sales commission or long-term incentives may be offered; Benefits: Generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more

Skills & Requirements

Key Requirements

• 2+ years Quality Engineering experience
• Medical device industry experience preferred
• Regulated industries experience required
• ISO 13485 experience preferred
• Process and manufacturing equipment validation
• PFMEAs and control plans
• Statistical analysis tools
• Nonconformances, CAPAs, process documentation
• Measurement System Analysis
• Test Method Validations
• Design History Review
• Bachelor's degree or higher in Engineering or Science
• Lean Six Sigma certification preferred

Work Rights