Quality Assurance Engineer II

5 days ago

Greenville, North Carolina, United States Attindas Hygiene Partners Full time $60,000 - $120,000 per year

Attindas Hygiene Partners
designs, manufactures, and markets absorbent hygiene products. The company sells adult incontinence and infant diapers, among other products, into the healthcare, retail, and direct-to-consumer channels under brands including Attends, Indas, and Comfees as well as a wide range of private label brands for retailers.

Mission:
We champion health, dignity and comfort.

Vision:
To be a global leader in absorbent hygiene by meeting consumers' diverse needs through effective, affordable and widely available personal care solutions.

Our Values:
Caring, Agile, Innovative, Unique, Personal, Genuine

Job Summary:
The QA Engineer II is responsible for ensuring QA System compliance and capability through ownership, development, implementation, and continuous improvement of quality systems within the site. The QA Engineer II is responsible for the daily QA lab activities and staffing.

Key areas of the role are:

Development, Implementation and Management of Quality Systems at the Site.

  • Owner of the sites quality systems to ensure compliance to the corporate quality system and site procedures.
  • 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
  • Provides updates and ongoing health checks of the processes.
  • Supports plant goals by implementing systems to support continuous improvement.

Leads/Supports All Internal and External Quality Audits.

  • Internal Audit Owner
  • GMP Monthly Inspection (Coordination and Metrics)
  • Leads / Supports External Audits as required.

Enhancing Operations Quality Capability & Ownership through Training, Coaching and Supporting

  • Provides site wide quality systems training, coaching and support
  • Leads the transfer of identified quality systems to the QA Technicians by providing system development, training and ongoing coaching
  • Leads various elements of the process control strategy
  • Backup product release support as needed
  • Serves as the backup to the QA manager as needed

Continuous Improvement

  • 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
  • Leads lab operations and supervises lab personnel
  • Perform other duties as assigned.

Required Qualifications/Professional Experiences:

  • Bachelor's degree in Engineering or related technical field
  • 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/Professional Experiences/Years of Experience:

  • Prior experience in a regulated manufacturing environment (Medical, Pharma or Food)
  • Advanced Microsoft office skills (excel, word)
  • Experience developing and implementing quality systems
  • Green Belt Six Sigma Training

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