Training and Records Coordinator
Manchester, NH
Full Time
Mid Level
Merrimack Manufacturing is seeking candidates for a Training and Records Coordinator roll. The roll will oversee the current records and training processes and identify opportunities for improvement in support of our organization’s future growth.
This role will report to the Lead QMS Engineer and contributes as a critical facilitator between HR, manufacturing, Quality, Operations, and project teams.
Responsibilities:
This role will report to the Lead QMS Engineer 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 all records generated within the Quality Management System are reviewed by the appropriate department prior to filing.
- 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.
- 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.
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