Open Position

Quality Assurance Engineer

  • Burnsville, MN

Basic Function

This Quality Engineer position will be responsible for sustaining existing medical device manufacturing lines for heart ablation catheters and associated capital equipment. The Quality Engineer implements, maintains and enforces the internal quality management system to meet ISO standards and FDA quality system regulations. This position develops and implements inspection/validation processes necessary to verify products meet requirements. This position works closely with manufacturing, regulatory, and development to establish/ensure compliance with the quality system throughout the product lifecycle.

Location: Must be able to work in Burnsville, MN

Compensation: The expected annual base salary range for this Minnesota-based position is $65,000-85,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits).

 

Apply Now →

Responsibilities

  • Initiates, owns, and resolves product nonconformance reports (NCEs) by performing root cause investigations and corrections.
  • Supports and owns Corrective Action and Preventative Action (CAPA) projects to improve the processes of the organization and its manufacturing processes.
  • Assists in defining and measuring process capability.
  • Develops process controls (inspections) and processes monitoring (sampling) for builders/operators to perform.
  • Executes process validations (OQ/PQ/PPQ and IMV/TMV)
  • Owns and participates on Change Orders (COs) to improve the Quality Management System (QMS) and manufacturing process.
  • Leads risk management and risk analysis activities (PFMEA).
  • Performs other related duties and responsibilities, as assigned.

Qualifications

  • Bachelor of science in engineering, science, or technical field
  • 0-2+ years’ experience in Engineering and/or Quality.
  • Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
  • Strong analytical and problem-solving skills.
Apply Now →
Imricor is an equal opportunity employer and encourages diverse candidates to apply.