Commercial Quality Engineer

Role Overview

• The Commercial Quality Staff Engineer is responsible for the oversight and execution of Quality Management Systems and compliance at the U.S. Pharma Distribution Centers.
• The Quality Engineer provides leadership and support of investigations, validations, quality system improvements, and audit readiness for the Distribution Center.
• Also monitors and reports on all quality system categories to assess compliance to GxP, regulatory, and standards.
• The Commercial Quality Staff Engineer serves as a single point of contact to the Commercial Quality Manager and Supply Chain partners on compliance related matters.
• Identifies business issues and opportunities to continuously improve quality and compliance and leads improvement opportunities and problem solutions.
• Implements and executes quality and compliance programs to ensure effective and consistent processes with established standards.

Requirements

• A minimum of Bachelor’s Degree is preferred.
• A minimum of 6 years of experience in a highly regulated industry is required.
• Quality and compliance experience in the Medical Device, Pharmaceutical or Consumer products industry and experience in distribution is preferred.
• Strong communication, teamwork, problem solving, decision-making, and root cause analysis skills are required.
• Experience with Warehouse Management Systems and SAP is preferred.
• Experience with Quality Event Management Systems such as Comet and/or EtQ is preferred.
• Proficiency in organizational and project management skills is preferred.
• Experience with Temperature Control is preferred.
• This position may require a 10% of domestic travel.

Benefits

• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year