Regulatory And Quality Systems Manager

Job Title: Regulatory Certification & Quality Systems Manager

Job Description

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 organizational awareness and discipline.
• Serve as the primary liaison with external certification bodies, testing laboratories, auditors, and regulatory agencies, representing the company in all regulatory and quality-related matters.

Essential Skills

• Bachelor’s degree in engineering, quality, manufacturing, regulatory compliance, business, or a related technical field, or equivalent professional experience.
• Proven experience developing, maintaining, or auditing an ISO 9001 quality management system.
• Experience with manufacturing quality systems, including document control, corrective-action programs, supplier quality, and internal audits.
• Ability to read and understand technical drawings, bills of material, product specifications, test reports, and engineering change documentation.
• Strong written communication skills with the ability to prepare clear, audit-ready procedures and compliance documentation.
• Experience working cross-functionally with engineering, manufacturing, service, suppliers, and executive leadership to implement quality and regulatory requirements.
• Hands-on experience with ATEX, IECEx, UL, CSA, INMETRO, or other hazardous-location certification programs.
• Experience interacting with notified bodies, certification agencies, test laboratories, or external auditors in support of product certification and surveillance activities.
• Capability to translate complex regulatory and certification requirements into practical, operational procedures and controls.

Preferred Skills & Qualifications

• Experience with gas detection, gas monitoring, environmental instrumentation, industrial sensors, electronics, or intrinsically safe equipment.
• ISO 9001 Lead Auditor or Internal Auditor training.
• Experience with intrinsically safe design documentation, explosion-protection concepts, product traceability, and controlled manufacturing processes.

This is a Contract to Hire position based out of Wadsworth, OH.

The pay range for this position is $40.00 - $52.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Wadsworth,OH.

This position is anticipated to close on Jul 22, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $40 - $52