Quality Engineer

Description:

About Computype

Since 1975, Computype has been a leading provider of track and trace solutions for critical applications in both industrial and healthcare markets. Over our history, innovation and striving to solve customer challenges have been at our core. Today, we offer a wide range of track and trace solutions, automation, and outsourced services to help our customers reduce labor, drive efficiency, and improve their workflows. With a continued focus on future technologies, we are leading the way with new solutions, applications and opening doors of automated intelligence, enabling better communication and data management, tailored for specific customer applications.

This in-person role is based at our headquarters in Saint Paul, MN.

Primary Objective of Position

The Quality Engineer acts as the primary owner of the customer complaint and corrective action process. This role ensures that manufactured products meet high standards through timely investigation, containment, and resolution, while maintaining strict compliance with ISO 9001 requirements and internal Quality Management System (QMS) procedures.

What You Will Do

• Complaint & CAPA Management: Manage the full lifecycle of customer complaints from initial receipt through final closure, ensuring all actions are executed on time.
• Investigation & Root Cause Analysis: Lead and document comprehensive root cause investigations for multiple concurrent projects.
• Risk Management: Apply risk-based thinking to evaluate the severity and impact of quality issues to determine the appropriate organizational response.
• Containment & Control: Oversee the segregation and production holds of nonconforming outputs to prevent further quality escapes.
• Traceability & Scope: Use product identification and traceability records to define the exact scope and impact of quality deviations.
• Communication: Develop clear, accurate written technical responses for customers and provide verbal status updates to internal stakeholders.
• Effectiveness Verification: Implement corrective actions and perform formal verification to ensure the underlying issues are resolved.
• Data & Improvement: Partner with the broader Quality team to analyze data trends, support management reviews, and drive continuous improvement.
• Audit Support: Serve as a key contributor during internal, customer, and third-party audits to demonstrate QMS effectiveness.
• Documentation: Maintain precise, controlled documented information for all complaints and CAPA activities.

Requirements:

• Experience: 2+ years in a similar role.
• Education: Bachelor’s degree in a technical field (Quality preferred). Equivalent combinations of education and experience—including degrees in Business, Project Management, or Communications—will be considered.
• QMS Knowledge: Working knowledge of ISO 9001:2015 or similar standards (e.g., ISO 13485, IATF 16949).
• Core Skills: Proven experience performing root cause analysis, interpreting engineering drawings/specifications, and managing multiple priorities to meet deadlines.

Preferred Qualifications

• Systems: Experience utilizing Epicor or comparable manufacturing ERP systems.
• Certifications: ASQ Certified Quality Engineer (CQE).
• Advanced Quality Tools: Experience with change management, document control, PPAPs, calibration management, and internal auditing.

Compensation & Benefits

Starting annual salary for this role is $65,000- $90,000 commensurate with experience. Benefits include Medical, Dental, Vision, Life Insurance, STD/LTD, Accident and Critical Illness Insurance, Pet Insurance, Generous PTO policy, 401(k) with match, Profit Sharing.

Equal Opportunity Employer: Veteran / Disability

We will consider all qualified Applicants for employment, including those with arrest or conviction records, in a manner consistent with the requirements of applicable state and local laws. In reviewing criminal history in connection with a conditional offer of employment, Computype, Inc. will consider the key responsibilities of the role.