Overview
Quality Engineer Jobs in Minnesota, United States at Invent Staffing
Title: Quality Engineer
Company: Invent Staffing
Location: Minnesota, United States
Job Title: Quality Engineer – Medical Devices
Location: Minnesota
Experience Required: 2+ years in the medical device industry
Key Responsibilities:
Develop and implement quality assurance processes to ensure compliance with FDA regulations (21 CFR 820), ISO 13485, and ISO 14971.
Conduct risk assessments and manage corrective and preventive actions (CAPA) to address product non-conformities.
Collaborate with cross-functional teams to support design control activities, including design verification and validation.
Perform internal audits to assess compliance with quality management systems and regulatory standards.
Assist in supplier quality management by evaluating and monitoring supplier performance.
Qualifications:
Bachelor’s degree in Engineering, Science, or a related technical field.
Minimum of 2 years of experience in quality engineering within the medical device industry.
Familiarity with FDA requirements (21 CFR 820), ISO 13485, and ISO 14971.
Strong problem-solving skills and attention to detail.
Excellent communication and interpersonal abilities.
Preferred Qualifications:
Experience with electronic and mechanical assemblies in a manufacturing environment.
Knowledge of Lean manufacturing practices.
Proficiency in quality control and assurance methodologies.
This role offers an opportunity to ensure the highest quality standards in medical device manufacturing, contributing to products that significantly impact patient care