Quality Engineer
- Minneapolis, MN
- $45.00-70.00 per hour
- Contract
- Full-time
- Provide quality engineering support to US Operations to ensure compliance with FDA regulations.
- Act as the first line support for quality issues and recommend quality improvements.
- Conduct and document root cause investigations of non-conforming processes and products.
- Facilitate Material Review Board meetings.
- Participate in or lead Corrective and Preventive Actions as appropriate.
- Review sampling techniques, methods, rationale, and test methods to ensure appropriateness.
- Review quality content in change control for products and processes.
- Review and author validation documents and validate processes.
- Initiate Change Requests to update documentation and processes.
- Perform data analysis, write summary reports, and other technical memoranda.
- Coordinate and support calibration activities, ensuring equipment is appropriately calibrated.
- Address out-of-calibration issues.
- Maintain applicable Quality Management System instructions.
- Support and participate in internal and external audits.
- Conform with the Code of Conduct and all local Compliance Standards.
- Conform with the Quality/EHS Policy.
- Perform other duties as assigned.
- Bachelor’s degree in a relevant science or engineering discipline.
- Experience in process validation, change control systems, and sample size determination.
- Familiarity with FMEA and various statistical techniques.
- Proficiency in analytical problem-solving.
- Excellent data analysis skills using statistical tools such as Minitab.
- Effective verbal and written communication skills.
- Ability to manage multiple projects and priorities.
- Strong computer skills, including proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Knowledge of FDA regulations (21 CFR Part 820) and related standards.
- Ability to apply standard techniques and procedures to perform assigned tasks.
- Judgment on details of work and developing skills in the operations quality function.
- Minimum of five years of related experience in medical device manufacturing.
- Experience with continuous improvement, Lean Six Sigma, or similar programs.
- Familiarity with geometric dimensioning and tolerancing.
- Experience performing internal audits.
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)