Associate Quality

FedExLawrence, IN
Onsite

About The Position

This position is responsible for the independent management, maintenance, and continuous improvement of a defined area of the Quality Management System (QMS), with day-to-day execution, governance, and effectiveness of assigned QMS processes. This position partners cross-functionally, supports audits and inspections, and ensures sustained compliance with regulatory, customer, and internal requirements. This position supports specific Quality functions at complex or highly regulated facilities or in a regional (multiple client/facility) capacity.

Requirements

  • Bachelor's degree in Quality, Engineering, Life Sciences, or a related field; 5 years of equivalent work experience may be considered.
  • Demonstrated experience independently managing one or more QMS elements.
  • Strong working knowledge of quality systems, procedures, and regulatory expectations.
  • Experience supporting audits and regulatory inspections.
  • Ability to follow policies and procedures.
  • Ability to read, write, and interpret information.
  • Ability to add, subtract, multiply, and divide.
  • Ability to use hands to finger, handle, or feel.
  • Ability to sit, walk, or stand for the duration of the shift.
  • Must possess visual acuity to perform essential job functions.
  • Ability to conduct physical tasks with a full range of motion throughout the warehouse environment.
  • Ability to lift/carry items up to 50 pounds.

Nice To Haves

  • Experience in regulated environments such as medical devices, pharmaceuticals, healthcare logistics, or food distribution.
  • Working knowledge of ISO-based quality systems (e.g., ISO 13485, ISO 9001), GMP, GDP, HACCP, FSMA, or similar frameworks.
  • Experience owning QMS processes such as Document Control, CAPA, Change Control, Training, or Complaints.
  • Experience using electronic QMS (eQMS) platforms.
  • Formal training or certification in Lean, Six Sigma, or quality risk management methodologies; Internal candidates to demonstrate QDM proficiency with QDM Expert certification.
  • High level of autonomy, accountability, and ownership.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Ability to interpret and apply regulatory and quality requirements.
  • Strong organizational and prioritization skills.
  • Proficiency with QMS platforms and standard business applications.
  • Ability to influence without direct authority and partner cross-functionally.
  • High level of integrity and attention to detail.

Responsibilities

  • Serve as the primary owner for assigned QMS processes (e.g., Document Control, CAPA, Change Control, Training, or similar).
  • Establish, maintain, and continuously improve procedures, workflows, and controls for assigned QMS areas.
  • Support day-to-day execution of assigned QMS processes, ensuring accuracy, timeliness, and compliance.
  • Review, assess, and approve quality records, documentation, and actions within assigned authority levels.
  • Monitor QMS performance metrics, trends, and risks related to assigned areas; drive corrective and preventive actions as needed.
  • Provide guidance, training, and support to cross-functional teams on QMS requirements and best practices.
  • Support internal, customer, and regulatory audits and inspections related to assigned QMS areas.
  • Partner with Quality leadership and cross-functional stakeholders to support site and organizational quality objectives.
  • Other duties as assigned.

Benefits

  • Competitive Pay: Competitive wages depending on your location and experience, paid bi-weekly for both full-time and part-time opportunities.
  • 401K plan with company match after 1 year
  • Tuition reimbursement program
  • Holiday pay and accrued paid time of programs ofering both Vacation and PTO
  • Medical, dental, vision, and voluntary benefits available on day one
  • Basic life insurance
  • Basic AD&D coverage
  • Supplemental Life and Supplemental AD&D
  • Short-Term and Long-Term Disability coverage for full-time employees after 180 days of service
  • Paid parental leave for both moms and dads
  • Paid bereavement and jury duty
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