Quality Assurance Specialist

Location: Troy, OH
Date Posted: 11-07-2017
Are you a Quality Assurance Professional with the ability to motivate and inspire your team to meet and exceed expectations?  Do you have an eye towards details and ensuring quality standards and requirements are been met or exceeded?  Do you want to work for a stable company that has been in business for nearly 100 years, truly values its customers and employees? Then we could have the right position for you!  If not, please share with your network.

 The Quality Assurance Specialist will support the quality management system throughout the company to ensure continued compliance to local Quality standards.

KEY RESPONSIBILITIES
  • The work load is distributed across: creating and updating documents, consulting databases, understanding procedures and customer requirements, creating reports
  • Will manage the quality systems databases for SOPs, training, change controls, CAPAs, validations, etc.
  • Creates new documents for QMS, trains others on new documents for, but not limited to:
    • Vendor selection, approval, performance measurement/management
      • SCAR process
    • Incoming material acceptance
    • Document control
    • Training
    • Change management
    • Process validation/spec creation
    • In process verification & testing
    • Material quarantine and disposition
    • Customer focus and requirements
    • Maintenance
    • Calibration
    • Management review process
    • Continuous improvement
  • Validates efficacy of CAPA
  • Administers and maintains QMS programs for ISO 9001:2015 compliance
 

SECONDARY DUTIES AND RESPONSIBILITES
  • Drive improvements to the quality system that ensures its suitability, sustainability, adequacy, and effectiveness
  • Completes vendor quality surveys
  • Responds to customer audit reports
  • Assists with customer complaint investigations using RCA tools
  • Recommends corrective actions for customer complaints, and recurring quality trends
  • Provide operational support related to defect resolution, product quality/risk assessment and product disposition
  • Other duties as deemed necessary
  • Maintains, reviews and updates QMS document systems and their integrity: monitors the timely and effective implementation of corrective actions and facilitates training for all organization members
  • Maintain Document Control System
  • Train personnel on document changes and assure correct implementation when applicable.
  • Provide information for Quality Systems Management Review by creating, retrieving, and preparing data in a meaningful format
  • Assists with internal QMS audits and Corrective actions for audit findings
     
KNOWLEDGE AND SKILLS REQUIRED:
  • Bachelors of Science
  • 5+ years with direct responsibility for ISO programs
  • ASQ certifications a plus, CQE, CQM, CQA
  • Experience in a CGMP environment a plus
  • Good math/data entry skills
  • Good organizational skills
  • Excellent interpersonal/communication skills
  • Strong written and verbal communication skills; strong presentation skills
  • Able to effectively work with various functions and levels within the organization
  • Ability to learn quickly, possesses a technical “can-do” aptitude
  • Experience handling multiple responsibilities with minimal direction
  • Coating, printing or laminating experience a plus

     
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