Quality and Regulatory Compliance Specialist

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

Position Objective

The Quality & Regulatory Compliance Specialist is responsible for managing product and process regulatory compliance activities while serving as a central point of contact for customer, supplier, government, and other external compliance-related questionnaires and information requests. 

This position develops a strong working knowledge of the Company's products, materials, manufacturing processes, supply chain, and regulatory requirements to provide accurate and timely responses and maintain effective compliance programs. The Specialist will work closely with suppliers and cross-functional internal teams to collect, validate, and maintain regulatory documentation and will coordinate with subject matter experts when specialized knowledge is required. This role requires strong attention to detail, excellent organizational skills, regulatory awareness, and the ability to manage multiple compliance activities and deadlines.

This in-office role requires working from our headquarters in Saint Paul, MN.

Key Responsibilities

Customer, Supplier & Government Questionnaires

• Serve as the primary point of contact for customer, supplier, government, and other external questionnaires, surveys, assessments, and information requests related to quality, manufacturing, supply chain, sustainability, regulatory compliance, and Company practices.
• Develop and maintain a strong working knowledge of the Company's processes, policies, procedures, products, and supporting documentation to independently research and respond to routine requests.
• Coordinate with internal subject matter experts across Quality, Operations, Engineering, Supply Chain, Environmental Health & Safety, Human Resources, and other functions to obtain, validate, and document information needed for specialized requests.
• Develop, organize, and maintain a centralized library of completed questionnaires, approved responses, supporting documentation, and other compliance-related information to promote consistency, reduce duplication of effort, and improve response times.
• Monitor incoming requests, establish priorities and deadlines, and ensure responses are complete, accurate, appropriately reviewed, and submitted on time.
• Identify recurring requests, opportunities for standardization, and process improvements that can increase the efficiency and effectiveness of the Company's questionnaire and information-request response process.

Regulatory Compliance

• Manage and maintain compliance programs related to REACH, RoHS, California Proposition 65, PFAS, TSCA, and other applicable restricted-substance, chemical-safety, and product regulatory requirements.
• Monitor applicable regulatory requirements and developments and assess their potential impact on Company products, materials, suppliers, and operations.
• Collect, review, and validate supplier declarations, material disclosures, Safety Data Sheets (SDSs), full material disclosure data, regulatory certifications, and other documentation necessary to demonstrate compliance.
• Collaborate directly with suppliers to obtain required compliance documentation, resolve material-related compliance questions, and address discrepancies or gaps in regulatory information.
• Maintain accurate, organized, and current regulatory compliance records, databases, and supporting documentation.
• Support internal and external audits, regulatory inquiries, customer requests, and other compliance-related activities by providing accurate documentation and reporting.
• Provide training and guidance to employees and relevant internal teams regarding applicable regulatory compliance requirements and processes.

Quality Engineering – As Workload and Priorities Permit

• 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

• Bachelor's degree in Environmental Science, Quality, Engineering, Supply Chain, Manufacturing, or a related field, or an equivalent combination of education and relevant experience.
• 2+ years of experience in regulatory compliance, product compliance, quality, manufacturing, environmental compliance, supply chain, or a related field; experience in a manufacturing environment strongly preferred.
• Working knowledge of product and chemical regulatory requirements such as REACH, RoHS, Proposition 65, PFAS, TSCA, or similar regulations; demonstrated ability to research and interpret regulatory requirements.
• Strong written and verbal communication skills, with the ability to gather information from multiple sources and translate complex or technical regulatory information into clear, accurate responses.
• Exceptional attention to detail and organizational skills, with the ability to manage multiple compliance programs, documentation requirements, requests, and deadlines simultaneously.
• Demonstrated ability to collaborate effectively with suppliers, internal subject matter experts, and cross-functional teams and to identify opportunities to improve compliance processes and documentation.

Preferred Qualifications

• Experience working with supplier material declarations, full material disclosures, SDSs, regulatory certifications, or restricted-substance compliance data.
• Experience responding to customer compliance questionnaires, supplier assessments, regulatory surveys, or similar external information requests.
• Experience developing or maintaining compliance databases, documentation systems, or centralized regulatory information repositories.
• Experience providing training or guidance on regulatory or quality requirements.
• Experience with calibration programs or processes including calibration records, schedules, measurement equipment, or calibration documentation.
• Experience supporting PPAP activities, including familiarity with PPAP documentation, submission requirements, inspection data, control plans, FMEAs, or related quality documentation.
• Familiarity with quality management systems, quality documentation, and manufacturing quality processes, particularly in a manufacturing environment.

Compensation & Benefits

Starting annual salary for this role will be $70,000 - $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.