Essential Duties and Responsibilities:
Performs gap assessments between Quality System procedures and EU Medical Device Regulation.
Develops quality plans for Quality System updates to changing regulations and standards.
Develops process flowcharts for use in creating Quality System procedures and processes.
Develops and implements procedures, forms and/or templates to assure compliance with Quality System Regulation, EU Medical Device Regulation and ISO 13485:2016 as well as other International regulatory requirements.
Initiate and complete Quality System change orders in Agile.
Reviews and approves quality system document changes for Quality requirements and compliance to applicable regulations.
Provides training on quality system requirements, as necessary.
Leads and/or participates in multi-departmental teams to implement Quality System updates, improvements and/or quality plans. Identifies specific action steps, accountabilities, and timelines for completion of projects.
Computer literate: able to use word processing and spreadsheet programs.
Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
Excellent written, verbal and presentation skills.
Excellent interpersonal skills to interact with all levels of the company and oversight agencies, sometimes in an adversary role.
Bachelor's degree or equivalent combination of education and experience.
Seven to ten years related experience in an FDA regulated industry with at least five years recent experience in Medical Devices or equivalent combination of education and experience.
Excellent working knowledge of medical device regulations (21CFR), ISO 13485, Medical Device Directive, EU Medical Device Regulation (in particular)
Certified Quality Auditor/Certified Lead Auditor desirable
Lead Auditor experience
Familiarity with the corrective action and internal audit processes related to the medical device industry
Experience with Agile Product Lifecycle Management system a plus
Resolve Quality Issue
Perform Statistical Analysis
Use Statistical Tool
Use Quality Tool