Quality Systems Engineer II

5 - 7 years experience  •  Information Services

Salary depends on experience
Posted on 11/22/17
Waco, TX
5 - 7 years experience
Information Services
Salary depends on experience
Posted on 11/22/17

Who is Domtar Personal Care?

Personal care is not just our business. It’s Personal. It’s a child, a loved one; it’s often about those that can’t help themselves. Caring for them can only be personal.  So Personal Care isn’t our category; it’s our calling, our mission.  We imagine the solutions that make caring for babies’ skin, and preserving dignity and independence easier and more affordable for everyone.  At Domtar, we believe everyone deserves personal care.

 

Our Vision

To be a global leader in absorbent hygiene by meeting consumers’ diverse needs through effective, affordable and widely available person care solutions.

 

Our Mission

We champion health, dignity and comfort

 

We serve consumers and caregivers wherever they access personal care, through healthcare, retail and direct channels.  We create value through our innovative solutions and achieve cost efficiency through operational scale, flexibility and the use of technology.

 

We are looking for a world class QA Systems Engineer II for our Waco, TX location.

 

The QA Systems Sr. Engineer is responsible for ensuring QA System compliance and capability through ownership, development, implementation and continuous improvement of quality systems within the site. The QA Systems Sr. Engineer is responsible for the daily QA lab activities and staffing.  More specifically, you will be responsible for:

Responsibilities

  • Development, implementation and management of Quality Systems at the site.
    • Owner of the sites quality systems to ensure compliance to the corporate quality system, site procedures and ISO 13485.
    • Provide updates and ongoing health checks of the processes
    • Support plant goals by implementing systems to support continuous improvement
    • Lead/Support all internal and external quality audits
    • Enhance operations quality capability & ownership through training, coaching and supporting
      • Provide site wide quality systems training, coaching and support
      • Lead the transfer of identified quality systems to the QA Technicians by providing system development, training and ongoing coaching
      • Backup product release support as needed
      • Serve as the backup to the QA manager as needed
      • Continuous Improvement
      • Lead lab operations and supervises/manages lab employees
      • Perform other duties as assigned
      • Document Control Site system owner
      • Internal Audit program owner
      • Mock Recall & Traceability process owner
      • Corrective & Preventative Action system owner
      • QMS training lead for the site
      • Electronic QMS System key user for the site
      • Others as assigned by QA manager
      • Internal audit owner
      • GMP monthly inspection (coordination and metrics)
      • Lead/Support external audits as required
    • Lead continuous improvement activities including transferring from a heavy product testing to online capability controls
    • Work across other sites to standardized best in class approaches / processes

 

Position Requirements

Requirements

  • Bachelor’s degree in Engineering
  • 5-7 years of experience implementing and managing quality systems
  • Experience developing and implementing site quality systems compliant with corporate requirements
  • Work effectively with teams and individuals
  • Strong IT skills, including MS Word, Excel, PowerPoint, and related MS Office applications
  • 1-3 years management and/or supervisory experience

Preferred Qualifications

  • Prior experience in a regulated manufacturing environment (medical, pharma or food)
  • Advanced Microsoft Office skills (excel, word)
  • Experience developing and implementing quality systems
  • Yellow Belt Six Sigma Training

Job ID #: 1551

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