EHS & Quality Systems Specialist

The EHS & Quality Systems Specialist supports the development, implementation, and continuous improvement of integrated Quality Management and Environmental, Health & Safety (EHS) systems in compliance with FDA 21 CFR Part 820, ISO 13485, OSHA, and EPA regulations.

This role ensures accurate documentation, training compliance, and regulatory alignment while promoting a culture of quality, safety, and environmental stewardship across all operations.

DUTIES AND RESPONSIBILITIES

Quality Systems Management

Maintain and control documentation (SOPs, Work Instructions, Forms) per FDA ALCOA+ principles.

Administer the Learning Management System (LMS) to ensure 100% training compliance for QA/QC, production, and operations personnel.

Support internal and external audits by preparing and maintaining audit-ready documentation.

Assist in investigations, CAPAs, and Change Controls, ensuring proper documentation, timely follow-up, and closure.

Record and track quality events, deviations, and non-conformances, ensuring data accuracy in electronic systems.

Collaborate with cross-functional teams to identify and implement process improvements in quality systems and compliance workflows.

Health, Safety & Environmental (HS&E) Compliance

Implement and maintain safety and environmental programs aligned with OSHA, EPA, and local regulations.

Lead and support incident management and root cause analysis, ensuring corrective and preventive actions are documented and completed.

Conduct and document safety inspections, risk assessments, and hazard analyses.

Coordinate and deliver safety training (lockout/tagout, chemical handling, PPE use, emergency response, etc.) through the LMS platform.

Monitor and maintain compliance with environmental permits, waste management, and spill response programs.

Support and engage in employee-led safety committees and site safety initiatives to promote proactive hazard prevention.

Foster a positive safety culture through visible leadership and consistent shop-floor engagement.

Data & Systems Administration

Manage data entry, verification, and reporting for both quality and HS&E metrics.

Generate and distribute dashboards and trend reports for training completion, audit findings, incident rates, and CAPA performance.

Support cross-functional teams with regulatory documentation for audits, inspections, and certifications.

Serve as a system administrator or key user for eQMS, LMS, and other compliance systems.

Continuous Improvement & Integration

Identify opportunities to streamline and align quality and safety documentation systems under a unified compliance structure.

Participate in and lead root cause analyses using tools like 5 Whys and Fishbone Diagrams.

Support development and revision of SOPs and training content to reflect updated regulatory and operational requirements.

Promote a culture of continuous improvement across all operational, quality, and safety domains. QUALIFICATIONS

Education:

Associate's or Bachelor's degree in Quality Management, Environmental Science, Engineering, or related discipline.

Experience:

2-5 years in quality systems, EHS, or regulatory compliance within a manufacturing or FDA-regulated environment (medical device, pharmaceutical, or chemical preferred).

Skills & Knowledge:

Strong understanding of FDA 21 CFR Part 820, ISO 13485, cGMP, OSHA, and EPA requirements.

Experience with LMS, eQMS, and safety management systems.

Skilled in Microsoft Office 365 (especially Excel, Word, PowerPoint).

Excellent organization, data management, and analytical skills.

Strong communication and presentation abilities across all organizational levels.

Ability to manage multiple priorities in a fast-paced, dynamic environment.

ASQ CQIA or OSHA 30 certification preferred. WORKING CONDITIONS

Environment:

Work is performed in both office and production floor environments.

May include time in non-temperature-controlled areas and routine interaction with production equipment and chemicals.

Physical Requirements:

Regular standing, walking, or sitting for extended periods.

Occasional lifting or moving of materials (up to 25 lbs).

Safety Standards:

Consistent use of required PPE including gloves, safety glasses, hard-toe shoes, and other protection as needed.

Schedule:

Standard weekday hours with occasional nights or weekends based on audit, training, or incident response needs.

Other:

This position is safety sensitive. It is subject to pre-employment and/or periodic background checks, motor vehicle records (MVR) and drug testing.

*This position description is a general guideline for work behavior and is not intended to be a comprehensive listing of all job duties. Therefore, it is also not, nor can it be implied to be, a contract of employment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential tasks. Must be able to successfully complete an intense background investigation.*