Regulatory And Quality Systems Manager

Job Description

Job Description

Job Title: Regulatory and Quality Systems Manager Job Description

We are seeking an experienced Regulatory Certification & Quality Systems Manager to establish, lead, and continuously improve the company's regulatory compliance and quality management programs. This role supports the design, manufacture, service, and calibration of advanced gas monitoring and analytical instrumentation. The position involves developing, implementing, and maintaining an ISO 9001-certified Quality Management System (QMS) and managing product certification programs for hazardous-location and safety compliance. The successful candidate will serve as the company's subject matter expert on regulatory compliance and quality assurance, ensuring all products meet applicable certification, safety, and quality requirements.

• Develop, implement, and maintain the company's ISO 9001 quality management system.
• Create and manage quality procedures, work instructions, document-control processes, corrective-action systems, supplier-quality processes, and internal-audit programs.
• Establish quality processes that support manufacturing, product service, calibration, repair, and technical support operations.
• Prepare the company for ISO 9001 certification audits and ongoing surveillance audits.
• Lead management reviews, internal audits, nonconformance tracking, corrective and preventive actions, and continuous-improvement activities.
• Support and manage company efforts related to ATEX, IECEx, and other hazardous-location certification programs.
• Work directly with certification bodies, notified bodies, test laboratories, consultants, and external auditors.
• Maintain certification files, technical construction files, quality documentation, test reports, drawings, bills of material, approved component lists, and compliance records.
• Assist engineering and manufacturing teams in understanding certification requirements and ensuring product changes are reviewed for certification impact.
• Support new product certification, product-line transfers, certificate maintenance, renewals, surveillance audits, and post-certification quality obligations.
• Develop quality-control procedures for incoming inspection, in-process inspection, final inspection, calibration, service, repair, and product release.
• Work with engineering and production teams to define inspection points, acceptance criteria, traceability requirements, and required production records.
• Establish supplier-quality expectations and assist with supplier qualification, corrective actions, and quality audits.
• Ensure certified products are manufactured, repaired, and documented consistently with approved certification requirements.
• 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/software changes, and manufacturing process changes are reviewed and documented.
• Maintain audit-ready records for ISO 9001, ATEX, IECEx, and related quality programs.
• Train internal personnel on quality procedures, regulatory requirements, documentation expectations, and certification-sensitive processes.

• Quality assurance
• ISO 9001
• Regulatory compliance
• Quality systems management
• Experience developing, maintaining, or auditing an ISO 9001 quality management system
• Experience with manufacturing quality systems, 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 documents
• Strong written communication skills and the ability to prepare audit-ready procedures and compliance documentation
• Experience working cross-functionally with engineering, manufacturing, service, suppliers, and executive leadership
• 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

• 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
• Familiarity with product transfer, acquisition integration, or certification maintenance after ownership or manufacturing changes
• Bachelors degree in engineering, quality, manufacturing, regulatory compliance, or a related technical field, or equivalent professional experience

This role is 100% on-site.

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

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

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 Contract to Hire position based out of Wadsworth, OH.

This position is anticipated to close on Oct 23, 2026.

This is a fully onsite position in Wadsworth,OH.

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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.