Quality Training & Records Coordinator

Job Description

Job DescriptionCOMPANY 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

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