Quality Engineer II- Medical Devices
$68,800–$123,800 year
On-siteMaple Grove, Minnesota, United States
Job Summary
Develop, implement, and maintain quality control plans and procedures for new and existing products while conducting root cause analysis to drive corrective and preventive actions. Perform statistical analysis of data to identify trends, validate processes, and develop measurement systems analysis studies. Participate in design reviews, support supplier quality activities including audits and qualification, and lead internal and external compliance audits. Collaborate with cross-functional teams to resolve quality-related problems and train junior personnel on quality methodologies. Prepare and present quality performance reports to management. Requires a Bachelor's degree in Engineering and two years of experience in a regulated manufacturing environment.
Required Qualifications
- Bachelor's degree in Engineering (Mechanical, Industrial, Electrical, or related field)
- 2 years of experience in a regulated Quality role within a manufacturing environment
- Strong understanding of quality management systems (e.g., ISO 9001, ISO 13485, IATF 16949)
- Proficiency in statistical process control (SPC), measurement systems analysis (MSA), and other quality tools
- Experience with root cause analysis methodologies (e.g., 8D, 5 Whys, Fishbone diagrams)
- Excellent problem-solving, analytical, and decision-making skills
- Strong communication and interpersonal skills, with the ability to work effectively in a team environment
- Ability to read and interpret technical drawings and specifications
Desired Qualifications
- Supplier Quality experience
- Knowledge of Six Sigma methodologies (Green Belt certification preferred)
- 2 years of experience in a regulated Quality role within a manufacturing environment, preferably in plastics injection molding or medical device industries
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