Quality Engineer

Quality Engineer

Support the Quality Management System (QMS) organization by working with design and manufacturing teams to complete operations quality activities. Use quality engineering concepts such as design control, process control, risk management, supplier quality, root cause analysis, statistical analysis, and continuous improvement activities. Ensure desired design and product performance requirements are met in compliance with regulatory, customer, and internal requirements. Skills in other technical areas such as verification testing and sterilization validation are desired. Engage in routine daily activities such as First Article Inspections (FAI), CAPA, NCMR, change order review, and training.

Function as the operation's quality representative during the execution of engineering projects.

Ensure product development projects and changes to existing products comply with the Quality System Regulations.

Conduct NCMR and CAPA investigation and reporting, assist in troubleshooting manufacturing problems and ensuring requirement compliance.

Collaborate with suppliers on NCMRs and supplier CAPAs.

Participate in cross-functional teams for the review and disposition of nonconforming products or components.

Develop and assist in maintaining Product Risk Management Files, including Risk Management Plan, Risk Assessments, DFMEA, PFMEA, and Risk Management Report.

Prepare and review documentation with a high degree of accuracy, completeness, and effectiveness.

Participate in developing Design Verification and Validation test plans/protocols and Process Verification and Validation test plans/protocols.

Provide guidance on Product Requirements compliance and direction for sample size and statistical analysis of Verification and Validation testing.

Participate in Design Reviews and FMEA Reviews.

Participate in complaint investigation and ensure investigations are thoroughly completed.

Provide direction to project teams on all Quality Policies/Procedures, including verification, validation, statistical methods, and design controls.

Assist in training of Special Work Orders, Receiving Inspection Processes, and FAIs.

3-5 years of experience in Medical Device (catheter focused), Quality Assurance, and Manufacturing Quality.

Proficiency in quality engineering concepts such as root cause analysis, continuous improvement, and quality standards.

Knowledge of ISO standards and validation processes.

Experience with Supplier Quality and Audits.

The pay range for this position is $52.00 - $57.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Brooklyn Park, MN.

This position is anticipated to close on Oct 3, 2025.