Quality Systems Specialist

6 days ago

Manchester, New Hampshire, United States Merrimack Manufacturing Full time $60,000 - $80,000 per year

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.

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