Regulatory Compliance and 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.

Position Summary  

The Quality & Regulatory Compliance Engineer ensures that materials, components, and products comply with global chemical regulations, including REACH, RoHS, Prop 65, PFAS, TSCA, and other restricted-substance directives. This role combines regulatory compliance expertise with quality engineering responsibilities. 

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

Primary Responsibilities Regulatory Compliance

• Manage and maintain compliance programs related to REACH, RoHS, Prop 65, PFAS, TSCA, and other restricted-substance or chemical-safety regulations.
• Collect, review, and validate supplier declarations, material disclosures, SDSs, full-material-disclosure data, and regulatory certifications.
• Collaborate with suppliers to resolve material-related compliance questions and ensure documentation accuracy.
• Maintain organized and current compliance documentation; provide timely reporting for regulatory updates, audits, or customer requests.
• Conduct internal training on regulatory compliance requirements as needed.

Quality Engineering

• Serve as the primary contact for compliance issues. 
• Participate in new part activities and lead PPAP submissions for new or changed parts. Assist Quality Engineers to complete validation and PPAP tasks including First Article Inspection (FAI), performance or functional testing, and report writing.
• PPAP / validation for purchased materials and components.
• Conduct root cause analysis for quality issues and implement effective corrective and preventive actions.
• Perform calibration, verification, and functional checks on instruments, gauges, and measurement devices according to established procedures. Maintain accurate calibration records, certificates, and documentation.
• Contribute to continual improvement initiatives.

Requirements

• B.S. degree in Engineering, Science, or equivalent experience.
• Minimum 4 years’ experience in a regulated manufacturing environment.
• Strong understanding of chemical regulatory frameworks (REACH, RoHS, Prop 65, PFAS, TSCA).
• Familiarity with ISO 9001; ISO 13485 or other quality system experience is a plus.
• Experience using Epicor or similar ERP system preferred.
• Ability to read and interpret engineering drawings, cGMP/GDP, GD&T, and detailed product specifications.
• Excellent verbal and written communication skills; proficiency in Microsoft Office Suite.
• Experience with change control, documentation practices, and revision management.
• Ability to manage multiple projects simultaneously and meet deadlines in a fast-paced environment.

Compensation & Benefits

Starting annual salary for this role will be $80,000 - $100,000 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.