Regulatory And Quality Systems Manager

Regulatory Certification & Quality Systems Manager

This role leads the development, implementation, and continuous improvement of the company's regulatory compliance and ISO 9001-certified Quality Management System (QMS) for advanced gas monitoring and analytical instrumentation. The position manages product certification programs for hazardous-location and safety compliance, including ATEX, IECEx, UL, CSA, QAN, QAR, and other domestic and international standards. You will serve as the primary subject matter expert and liaison for regulatory compliance and quality assurance, partnering closely with Engineering, Manufacturing, Service, Supply Chain, and leadership to integrate quality and regulatory requirements throughout the product lifecycle.

This is a highly visible, hands-on leadership role ideal for someone who enjoys building robust systems from the ground up and fostering a culture of quality, regulatory compliance, and continuous improvement.

Responsibilities

• Develop, implement, and maintain an ISO 9001-compliant Quality Management System that supports the design, manufacture, service, calibration, repair, and technical support of advanced gas monitoring and analytical instrumentation.
• Create and manage quality procedures, work instructions, document-control processes, corrective-action systems, supplier-quality processes, and internal-audit programs that are practical and aligned with operational needs.
• Prepare the organization for initial ISO 9001 certification audits and ongoing surveillance audits, ensuring systems, records, and processes remain audit-ready at all times.
• Lead management reviews, internal audits, nonconformance tracking, corrective and preventive actions, and continuous-improvement activities to drive measurable quality and compliance improvements.
• Support and manage company efforts related to ATEX, IECEx, and other hazardous-location certification programs for gas detection and gas monitoring equipment.
• Work directly with certification bodies, notified bodies, test laboratories, consultants, and external auditors to plan, coordinate, and execute certification and surveillance activities.
• Maintain comprehensive certification files, technical construction files, quality documentation, test reports, drawings, bills of material, approved component lists, and compliance records for all certified products.
• Assist engineering and manufacturing teams in understanding certification requirements and ensure that product changes are properly reviewed, documented, and evaluated for certification impact.
• Support new product certification, product-line transfers, certificate maintenance, renewals, surveillance audits, and post-certification quality obligations in global markets.
• Develop quality-control procedures for incoming inspection, in-process inspection, final inspection, calibration, service, repair, and product release to ensure consistent product quality and compliance.
• Collaborate with engineering and production teams to define inspection points, acceptance criteria, traceability requirements, and required production records for certified products.
• Establish clear supplier-quality expectations and assist with supplier qualification, corrective actions, and quality audits to ensure supplier performance supports certification and quality requirements.
• Help ensure that certified products are manufactured, repaired, and documented in strict accordance with approved certification requirements and controlled processes.
• Develop and maintain a controlled-document system for procedures, forms, drawings, manufacturing records, quality records, and certification documents.
• Ensure product changes, supplier changes, component substitutions, firmware and software changes, and manufacturing process changes are properly reviewed, approved, and documented in alignment with regulatory and certification requirements.
• Maintain audit-ready records for ISO 9001, ATEX, IECEx, and related quality programs to support internal, customer, and external audits.
• Train internal personnel on quality procedures, regulatory requirements, documentation expectations, and certification-sensitive processes to build…