Quality Systems Engineer

Job Description

The Quality Systems Engineer (QSE) will be responsible for drive key components of the Quality Management System (QMS), including GMP requirements.  The QSE will partner closely with Production Engineers and Logistics Supervisors to drive continuous improvement activities.

Responsibilities

• Lead the Internal Audit program for the site
• Drive continuous improvement of our quality QMS KPI metrics, and drive CAPA plans to completion
• Act as gatekeeper and other roles within the Management of Change (MOC) system
• Support and/or lead key components of customer and third-part audits for the site
• Lead quality efforts related to the Supplier Management program for the site
• Leads GMP program for the site, including:
  • Remain contemporary to the GMP requirements via training
  • Co-lead the Food Safety Defense team (FSD), lead HACCP efforts.
  • Assure GMP & FSD training is contemporary, and that employees are trained to requirements
  • Administer the Pest Control program
  • Establish validation plans and execute accordingly to support MOC process
  • Lead and administer the GMP internal audit program
  • Develop improvement plans to reduce product contamination and ensure compliance with internal GMP standards for equipment control & maintenance.
  • Participate in and/or lead key components of customer complaint investigations for GMP products (packaging, labeling, and fit-for-use)

Required Qualifications

• BS Degree in Engineering (Alternative STEM degrees will be considered)
• 1-5 years of experience in a quality related role
• Must be able to maintain focus on Safety and Environmental in all activities and wear requisite PPE
• Excellent communication (verbal and written) and strong organizational and prioritization skills, and the proven ability to lead and influence others are critical for success
• The ability to lead investigations for cross-functional teams; use & apply continuous improvement tools to determine root cause and CAPA plans; and perform CAPA verification activities
• Organize and prioritize multiple tasks and changing priorities, lead and/or participate on cross-functional teams and troubleshoot quality problems
• Ability to learn processes quickly and make data driven decisions/ implement recommendations, with an understanding of SPC being a key skill
• Clear understanding of ISO 9001:2015 and application to a manufacturing site, including document control requirements

#WRGRACE

Preferred Qualifications

• Chemical Industry background
• GMP knowledge
• Training/ background in ISO 9001:2015 including performing audits
• Six-Sigma and Lean experience
• ASQ CQA and/or CQE certification

Benefits

• Medical, Dental, Vision Insurance
• Life Insurance and Disability 
• Grace Wellness Program
• Flexible Workplace 
• Retirement Plans  
• 401(k) Company Match – Dollar to dollar up to the first 6%
• Paid Vacation and Holidays
• Parental Leave (salaried only)
• Tuition Reimbursement 
• Company Donation Match Program

U.S. Employee Benefits Summary (grace.com)