Quality Engineer Process Support

Job Title: Quality Engineer Process Support
Location: Arden Hills, Minnesota

Employment Type: Contract (13 Months) Onsite

• Provide hands-on quality engineering support to medical device manufacturing and production teams.

• Investigate manufacturing process issues, identify root causes, and implement effective corrective actions.

• Independently manage CAPAs from initial investigation through implementation and effectiveness verification.

• Lead nonconformance investigations, including root cause analysis, impact assessments, containment, and corrective action planning.

• Work closely with Manufacturing Engineering, Operations, and Quality teams to improve manufacturing processes and product quality.

• Provide technical guidance to production personnel on quality requirements, process deviations, and troubleshooting.

• Lead manufacturing process changes, including documentation, risk assessments, approvals, and implementation.

• Evaluate process changes for their impact on product quality, manufacturing performance, and regulatory compliance.

• Support change control activities and ensure compliance with established quality management systems.

• Identify recurring quality issues and implement sustainable process improvements.

• Maintain accurate investigation records and quality documentation in accordance with applicable medical device standards.

• Bachelor's degree in Engineering or a related technical discipline, or equivalent relevant experience.

• Strong experience in Quality Engineering within a regulated medical device manufacturing environment.

• Proven ability to independently manage CAPAs, nonconformance investigations, and root cause analysis.

• Extensive experience supporting manufacturing processes and resolving production-related quality issues.

• Strong understanding of manufacturing process controls, process changes, and quality management systems.

• Experience working directly with production personnel, Manufacturing Engineers, and cross-functional teams.

• Hands-on experience with Windchill, particularly document control, engineering changes, or quality processes.

• Demonstrated experience executing process improvements and corrective actions.

• Strong analytical, investigative, and systematic problem-solving skills.

• Ability to independently manage complex quality issues and provide technical guidance.

• Background in Electrical Engineering, Electronics Manufacturing, or Electromechanical Devices.

• Experience manufacturing sensors, sensor-based products, or similar electronic medical devices.

• Experience using SAP in a manufacturing or quality environment.

• Familiarity with ISO 13485, FDA quality system requirements, and regulated manufacturing practices.

• Knowledge of 5 Whys, Fishbone Diagrams, FMEA, and 8D problem-solving methodologies.

Health Insurance:
Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits:
A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO):
No PTO other than that required by applicable state and local laws.