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EU MDR Remediation Workstream Lead

Company:
Lancesoft Inc.
Location:
Acton, Massachusetts, United States
Posted:
October 17, 2019

Description:

EDUCATION and/or EXPERIENCE:

– Bachelor’s Degree in Engineering

– 10-15 years’ experience working as a system engineer in a product development environment

SKILLS, KNOWLEDGE AND EXPERIENCE REQUIRED:

Strong computer skills and knowledge of MS Word, MS Excel, Access, Outlook and MS Vision

– MS Project scheduling is desired

– Must have strong verbal and interpersonal communication skills

– Strong English writing, editing and grammar skills

– Excellent organizational, planning and project management skills

– Must display a positive attitude while maintaining flexibility

- Team player with ability to facilitate meetings with cross functional teams located on site and abroad.

QUALITY AND REGULATORY REQUIREMENTS:

Quality system knowledge including Design History File Knowledge, labeling

– Establishes, implements and maintains the quality system in accordance to FDA Regulations, ISO 13485, European Union Medical Device Directive

– Completes and documents all required quality, business and departmental training

KEY REPONSIBILITIES INCLUDE:

Planning and controlling project to remediate design history file documentation for medical devices

– works with departmental managers, leaders and subject matter experts to review and assist in creating documentation that will support product testing, data collection, risk management and process flow

– Performs gap analysis of current practices and procedures

– Create, update and maintain trending charts as requested

– Other projects or tasks as assigned