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Safety and Compliance Specialist

2 months ago

Andover, United States MP RPO Full time
Job DescriptionJob Description

Summary

The Safety and Compliance Specialist is a support role that is responsible for the use, maintenance, development, and continued improvement of OSHA-regulated safety systems and FDA-regulated quality systems. This role is well-suited for an individual that is self-motivated, detail-oriented, research-driven, and invested in the safety, efficacy, and quality of medical devices and the safety and wellbeing of personnel. This role is also well-suited for a candidate with some understanding of OSHA and/or FDA regulation, who is looking to significantly build on their knowledge.

Responsibilities

FDA and OSHA-compliant systems are in place at NEOLab. This role will function to use and improve these systems, while ensuring ongoing compliance to applicable regulations. This role will report directly to the Content Director.

The Safety & Compliance Specialist will:

  1. Help establish written policies and work procedures that will create and maintain a safe workplace (OSHA);
  2. Ensure employees are properly trained on health and safety practices and regulatory standards (OSHA);
  3. Manage the safety system to ensure ongoing compliance and continued improvement (OSHA);
  4. Identify and investigate compliance issues, irregularities, and violations (OSHA);
  5. Help establish quality documentation for medical devices that will ensure acceptance criteria for production processes (FDA);
  6. Engage with the quality system for maintenance purposes; collect and analyze data on complaint trending, equipment function, internal auditing, and the like (FDA).
  7. Identify and investigate compliance issues, irregularities, and violations (FDA).

Description of Tasks

  1. Completing safety orientation with new hires to show the locations of safety equipment, evacuation routes, external meeting points, and potential hazards.
  2. Conducting periodic testing and inspections on safety equipment and supplies.
  3. Create and maintain records of compliance activities related to OSHA systems.
  4. Investigate production processes for documentation purposes, as related to FDA systems.
  5. Track and issue training documentation records as related to FDA systems.
  6. Tracking and analyzing medical device complaints as related to FDA systems.
  7. Preparing and filing compliance reports related to FDA systems.
  8. Assorted other tasks, as time permits.

Qualifications

  1. High School Diploma/GED or Equivalent Experience.
  2. Effective written and verbal communication, public speaking, analytical thinking, and problem-solving.
  3. Ability to understand formal, regulatory language and convert into actionable items.
  4. Demonstrated ability to manage safety initiatives and effectively implement employee safety and training procedures
  5. Ability to work for extended periods of time sitting, bending, reaching, and speaking on a constant basis
  6. Ability to work for extended periods of time standing, walking, kneeling, pushing and pulling on an occasional basis