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Quality Training & Records Coordinator
Quality Training & Records CoordinatorMerrimack Manufacturing • Manchester, NH, US
Quality Training & Records Coordinator

Quality Training & Records Coordinator

Merrimack Manufacturing • Manchester, 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 :

  • This positon will oversee the current records and training processes and identify opportunities for improvement in support of our organization’s future growth and contributes as a critical facilitator between HR, manufacturing, Quality, Operations, and project teams.

    • RESPONSIBILITIES :

  • Administration of the overall training program and coordination of the appropriate personnel to facilitate and document training activities.
  • Provide Good Documentation Practices, QMS or other training to new hires, or as new processes are launched.
  • Develop Classroom Training material for complex processes and ensure all training is processed in a timely manner.
  • Work with Document Control to support part number management, QMS reporting, and process improvement.
  • Contribute to cross-functional improvement initiatives as a subject matter expert for records coordination and training.
  • Responsible for the proper organization, filing, archiving, and secure destruction of all controlled documents whether electronic or paper.
  • Ensure that the appropriate department reviews prior to filing all records generated within the Quality Management System.
  • Participate in processing effective documents via Periodic Review - for accuracy, completeness, and impact to other documents.
  • Responsible for the proper formatting and editing of documents prior to submitting for approval.
  • Support the maintenance of design history files, device master records, and device history records as needed.
  • Assist in all audits including FDA and Notified Bodies.
  • Proactively interface with internal and external customers to convey requirements, resolve issues, fulfill documentation requests, and otherwise facilitate the change process.

    • QUALIFICATIONS AND SKILLS :

  • Strong presentation skills, comfortable with compiling information for groups of different professions and levels of management.
  • Experience in MCSFT Power Point, electronic management systems, record retention, filing, and developing organization systems.
  • Organized, detail oriented, and self-directed; able to meet goals and deadlines without constant supervision. 2+ years of experience working within a regulated industry.
  • Familiarity with GDP and working in the medical device field preferred.
  • Familiarity with ISO 9000 and / or ISO 13485 preferred.
  • Team player who prefers to take a collaborative approach in problem solving.

    • EDUCATION :

  • Bachelor’s in Engineering or related experience   Powered by JazzHR
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