Quality Training & Records Coordinator
Manchester, NH
Full Time
Quality
Experienced
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:
QUALIFICATIONS AND SKILLS:
EDUCATION: Bachelor’s in Engineering or related experience
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
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