Senior EHS Manager

PROMED MOLDED PRODUCTS INC•Plymouth, MN

1d•$127,935 - $176,550•Onsite

About The Position

The Senior EHS Manager is responsible for leading and executing the Environmental, Health & Safety strategy for ProMed. This role ensures compliance with OSHA, EPA, FDA (21 CFR Part 820), ISO 13485, ISO 14001, and ISO 45001 standards while fostering a proactive safety culture across operations. The Senior EHS Manager partners cross-functionally with Quality, Engineering, Facilities, and Manufacturing as well as Pharma to integrate EHS requirements into all aspects of the business. The Senior EHS Manager ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.

Requirements

Bachelor’s degree in environmental health & safety, Environmental Engineering, Industrial Hygiene, Occupational Safety, or related field required.
8–12+ years of progressive EHS experience in manufacturing.
3–5+ years in medical device or FDA-regulated environment preferred.
Experience leading regulatory inspections and ISO audits required.
Strong knowledge of OSHA 29 CFR 1910, EPA regulations, RCRA, and DOT requirements.
Familiarity with FDA QSR (21 CFR Part 820) and ISO 13485.
Understanding of ISO 14001 and ISO 45001 management systems.
Strong analytical and problem-solving skills.
Excellent written and verbal communication skills.
Proven leadership and change management ability.

Nice To Haves

Master’s degree preferred.
Experience in cleanroom operations is strongly preferred.
Certified Safety Professional (CSP)
Certified Industrial Hygienist (CIH)
Certified Hazardous Materials Manager (CHMM)
ISO 14001 / ISO 45001 Lead Auditor
OSHA 30 or OSHA 500
Experience in injection molding, precision manufacturing, or sterilization processes preferred.

Responsibilities

Ensure compliance with federal, state, and local EHS regulations (OSHA, EPA, RCRA, DOT, etc.).
Maintain all required environmental permits and regulatory reporting.
Lead regulatory inspections, customer audits, and ISO audits.
Oversee compliance with ISO 14001 and ISO 45001 management systems.
Support FDA QSR (21 CFR Part 820) and ISO 13485 compliance as it relates to EHS.
Manage EHS-related CAPAs and corrective actions.
Oversee hazardous waste management, chemical storage, and disposal programs.
Manage air emissions, wastewater discharge, and stormwater compliance.
Monitor and reduce environmental impact (waste, energy use, sustainability initiatives).
Ensure proper ventilation and exhaust systems for cleanrooms and molding operations.
Develop, implement, and maintain site-wide safety programs.
Conduct risk assessments, Job Hazard Analyses (JHA), and industrial hygiene monitoring.
Manage programs including: Lockout/Tagout (LOTO), Machine guarding, Ergonomics, Confined space, Respiratory protection, Hazard communication.
Lead incident investigations and root cause analysis.
Track and improve safety KPIs (TRIR, DART, LTIR).
Develop emergency response and business continuity plans.
Ensure safe handling of medical-grade polymers, solvents, and sterilization chemicals.
Partner with Quality and Engineering on process FMEAs and risk assessments.
Monitor employee exposure levels and maintain industrial hygiene programs.
Support new equipment installation and process validation from an EHS perspective.
Lead and develop the EHS team.
Drive safety culture initiatives and employee engagement programs.
Deliver safety training programs and maintain compliance records.
Prepare and present EHS metrics to executive leadership.
Manage EHS budget and capital improvement projects.
Establishes and cultivates a network of support (laboratory, quality, manufacturing, engineering, sales, and marketing) to facilitate completion of assignments.
Performing other duties as assigned.