EHS & Quality Systems Specialist

Grove City, OH - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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:
- Associates or Bachelors degree in Quality Management Environmental Science Engineering or related discipline.
Experience:
- 25 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.*

Required Experience:

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 ...

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:
- Associates or Bachelors degree in Quality Management Environmental Science Engineering or related discipline.
Experience:
- 25 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.