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Quality, Safety, & Environmental Manager - Warehouse Setting

Manufacturing company in Durham, NC is seeking an experienced Quality & Safety Manager for their warehouse. $75,000 to $80,000 depending on experience.

Job Description:

• Act to embed and continually improve our ISO systems and maintain business accreditations.
• Assume a leadership role with authority for the development, implementation, evaluation, and maintenance of comprehensive and effective Quality and Environmental Health and Safety (EHS) programs that comply with FDA regulations, ISO requirements, and other applicable regulatory bodies and standards as well as corporate documents and requirements.
• Perform as Site lead during routine and non-routine audits or inspections of the facility by the FDA, EPA, ISO, or other regulatory groups and/or customers.
• Responsible for supplier qualification, audits, and periodic assessments.
• Lead and/or support the investigation of EHS incidents, customer complaints, deviations, and failure investigations, crisis management technical data review, recall and traceability meet customer and audit standards, identification of root cause and closure of action.
• Be proactive in reducing accidents and injuries that increase Workers' Compensation spending
• Serve as the subject matter expert for OSHA federal, state and local regulations.
• Lead the planning and execution of our internal audit program as well as monitor risk assessments in order to improve compliance and mitigate risk
• Provide leadership to department under responsibility and coach, mentor and develop direct reports; manage a high performing team that delivers continuous improvement, and stakeholder added value.
• Coach leaders and managers in order to improve business performance through Quality Safety, and Environmental development, engagement and wellbeing of their teams.
• Establish, track and control, and report upon EHS and Quality KPIs..
• Identify areas of microbial risk and ensure corrective actions are implemented.
• Supervise and train salaried and hourly employees within the FSQA departments.
• Must be willing to travel to various regions, as needed.
• Ensure customer requests are completed appropriately and timely.
• Prepare and manage department budget
• Follow all food safety requirements and GMP's as applicable for this position
• Evaluate and recommend new processes that will increase efficiencies for the business
• Other duties as assigned.

Qualifications:

• Minimum of three to five years in a Food Safety and/or Medical Device related field.
• Three to five years of supervision experience required.
• Manufacturing Food Safety and/or Medical Device related experience, strongly preferred.
• Technical knowledge of regulatory requirements, inclusive of FSMA, microbial hazards, third party audit bodies, sanitation procedures and field and plant operations.
• Strong written and verbal communication skills in English are required.
• Must have the ability to make decisions, appear for work on time, follow directions, interact well with co-workers, understand, and follow posted work rules/procedures.
• Must be self-motivated and able to keep projects moving forward under stressful conditions. Changing priorities will be a persistent factor.
• Ability to work and adapt to a fast-paced, dynamic environment.
• Must be well versed in ISO 13485 and ISO 9001:2015
• Lead Auditor ISO 13485:2016 preferred
• Lead Auditor ISO 99001:2015 preferred
• Must be well versed in CFR 1910 General Industry standards
• Knowledge of DOT regulations

Physical Demands:

• While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• The employee is occasionally required to sit.
  The employee must frequently lift and/or move up to 50 pounds.

Work Environment:

While performing the duties of this job, the employee is regularly exposed to moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually moderate, but hearing protection may be required depending on the department where the employee is assigned.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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