SUMMARY

The Regulatory Compliance Manager is responsible for developing, policies, procedures and systems to ensure manufacturing process and product compliance to Federal, State and International environmental and consumer safety regulations. Included but not limited to DEP, EPA, FDA, CONEG, EU REACH and Proposition 65. This position is also responsible for maintaining knowledge of current environmental and consumer safety laws and regulations. This position will work closely with the Director of OPEX and Senior Management to develop, maintain and continuously improve the compliance processes within the QMS.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Provides governance and quality oversight of Environmental and Regulatory programs

• Develop and oversee control systems to manage potential and actual regulatory and compliance issues

• Attain compliance by isolating and resolving non-compliance issues; recommends product and process changes

• Conducts comprehensive audits of company sites for compliance to Environmental and Regulatory programs

• Prevents compliance issues by collaborating with production and other departments

• Lead corrective action resulting from external Quality System Audits

• Provide Compliance training

• Facilitate the ArcWay Quality Management System initiatives

• Participate in the Quality System management review

• Participates in industrial conferences and benchmarks top performing organizations for program improvement

• Participate in Continuous Improvement efforts to ensure customer satisfaction and compliance with the QMS

• Facilitate corrective and preventive action by utilizing Quality tools:

• Root Cause Analysis

• Failure Modes and Effects Analysis (FMEA)

• 5 Why Analysis

• Fishbone Analysis

• Gauge R&R

• Design of Experiments

SUPERVISORY RESPONSIBILITIES

This position supervises the Compliance Specialist. This position also will be responsible for leading cross functional teams during quality improvement initiatives.

KNOWLEDGE AND SKILLS The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Produce high quality, timely and cost-effective solutions to ensure compliance with applicable Federal, State and local regulations

• Extensive ISO 9001: 2015 Quality Management Experience

• Extensive ISO 14001 Environmental Management System experience

• Extensive Regulatory experience (FDA, CONEG, Prop 65, EU REACH)

• Applies fundamental problem solving concepts to project work and identified issues to provide root cause analysis and issue resolution

• Working knowledge of quality tools such as FMEA, 5 Why, Fishbone Analysis, Gauge R&R, Design of Experiments, SPC, SQC, Mistake Proofing/Poka-Yoke and statistical sampling.

• Project management experience

EDUCATION AND WORK EXPERIENCE

• BS or advanced degree in Chemistry, Toxicology or other related fields

• Minimum 5 years Regulatory Compliance experience. Preference in Heavy Industry / Process Manufacturing

CERTIFICATES, LICENSES, REGISTRATIONS

• ISO 14001 Environmental Management System experience required

• ISO 9001 Quality Management System experience required

PHYSICAL DEMANDS/WORK ENVIRONMENT

Production/Warehouse/Office Environment

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Work Location: One location

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