Quality Engineer: Compliance & Root-Cause Excellence

Medbio, LLC; Grand Rapids (MI); On-site; USD 65,000 - 95,000; Full time

Job summary

Medbio, LLC in Grand Rapids, MI is seeking a Quality Engineer to support customer complaints and corrective actions while assisting Engineering and quality systems in a cGMP environment. The role focuses on root-cause analysis, PFMEA, and control plans, ensuring production records comply with SOPs.

Responsibilities include reviewing documentation, creating MRBs, supporting IQMS procedures, and providing training materials. Strong communication and teamwork are essential for success.

Qualifications

• Four-year degree or equivalent in years’ experience in Quality-related field.
• Two years or more involved in plastic injection molding.
• Preferred experience in a medical device manufacturing environment.
• Understanding of ISO/FDA requirements with regard to manufacturing and document control.
• Good written/verbal communication skills.
• Good blueprint reading; GD&T experience a plus.
• Self-motivation and ability to manage QE portions of complex projects with deadlines.
• Proficiency with Microsoft Office.

Responsibilities

• Learn and apply ISO/FDA requirements and raise awareness among employees.
• Field Customer Complaints and SCARs and drive root-cause with documented actions.
• Assist Engineering with protocol planning, part evaluation, and execution as needed.
• Assist risk analysis activities including PFMEA, Process Flow, and Control Plans.
• Review production documentation for completeness and SOP compliance.
• Create MRBs and assist investigations and disposition of suspect material.
• Provide input to QA/RA IQMS procedures and training materials.
• Provide backup sign-off for Protocols, Reports, DCNs and deviations.
• Assist Mold Qualification review of dimensional results and paperwork.

Skills

Written communication

Verbal communication

Leadership

Interpersonal skills

Motivational skills

Self-motivation

Blueprint reading

GD&T experience

Project management

Education

Four-year degree in quality-related field

Tools

Microsoft Office

Job description

Medbio, LLC in Grand Rapids, MI is seeking a Quality Engineer to support customer complaints and corrective actions while assisting Engineering and quality systems in a cGMP environment. The role focuses on root-cause analysis, PFMEA, and control plans, ensuring production records comply with SOPs.

Responsibilities include reviewing documentation, creating MRBs, supporting IQMS procedures, and providing training materials. Strong communication and teamwork are essential for success.