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Quality Systems Specialist

Quality Systems Specialist

Merrimack ManufacturingManchester, NH, US
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COMPANY OVERVIEW :

  • Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard.
  • We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life.

POSITION OVERVIEW :

  • The Quality Systems Specialist is responsible for assisting the in managing and maintaining the organization’s document control processes, ensuring all controlled documents are accurate, up-to-date, and compliant with regulatory requirements.
  • Additionally, this role supports the broader Quality Management System (QMS), assisting with process improvements, audits, and compliance initiatives to uphold product quality and regulatory standards.

    • RESPONSIBILITIES :

  • Support change control administration, part number management, BOMs and BOM structure, and applying revision control within the Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems.
  • Review all changes in a timely manner with a high level of detail.
  • Ensuring documents follow proper formatting and editing prior to submitting for approval.
  • Support the proper organization, filing, archiving, and secure destruction of all controlled documents, whether electronic or paper.
  • Proactively interface with internal and external customers to convey requirements, resolve issues, fulfill documentation requests, and otherwise facilitate the change process.
  • Review change orders for accuracy, completeness, and impacts to other documents, products, processes, and the PLM or ERP systems.
  • Provide Good Documentation Practices guidance to the team as needed.
  • Support continuous improvement initiatives within document control workflows and the broader Quality Management System (QMS).
  • Support system configuration and testing as needed Develop a comprehensive understanding of Merrimack products and processes, leveraging this knowledge to enhance QMS effectiveness.
  • Support collection, analysis, and trending of QMS data.
  • Support internal and external audits.

    • QUALIFICATIONS AND SKILLS :

  • 1+ years of experience administering processes within a database.
  • Strong written and verbal communication skills.
  • Advanced proficiency in Microsoft Word, including manipulation of headers / footers, page layout control, document sections, orientation, styles, and tracked changes.
  • Strong computer skills with databases and software applications.
  • Project coordination and / or project management experience.
  • Demonstrated aptitude for learning technical information quickly and accurately.

    • EDUCATION :

  • Bachelor’s degree in Science, Engineering, or a related field.   Powered by JazzHR
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    Quality Specialist • Manchester, NH, US