Senior Post-Market Reliability Engineer, CS
Medtronic
Sr Manager, Document Control
Diabetes Youth Families
full-time
Posted on:
Origin: • 🇺🇸 United States • Massachusetts
Visit company websiteSalary
💰 $136,650 - $204,975 per year
Job Level
Senior
About the role
- Serves as QMS Process Group Owner for Document, Record & Change Controls.
- Leads the development and roll-out of document control tools.
- Lead implementation of Change Order Training & Certification Program.
- Provides oversight of project contractors and vendor resources.
- Supports business initiatives, identify trends and recommends and implements best practices to ensure scalability and growth.
- Maintains a watchful and alert attitude toward the Document Control process, including developing routine reports and metrics to gauge success.
- Provide inputs to Monthly Data Analysis and Management Review, as required.
- Leads or participates as the QMS representative in Document & Record Control improvement projects.
- Works cross-functionally to improve the content in change orders for approval.
- Manages and develops document control staff at various levels.
- Creates a strong, high performing team with a collaborative culture and customer centric mindset.
- Performs other duties, as required.
Requirements
- Typically requires a four-year degree from an accredited University or a combination of education and relevant work experience.
- Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) ISO 13485 quality system standards.
- A minimum of 10 years’ work experience in a regulated industry, preferably medical device, minimum of 5 years in a Quality Assurance or Regulatory Affairs role, minimum of 5 years of managerial experience.
- FDA and ISO 13485 Certification inspections.
- Working knowledge of 21 CFR Part 11 and experience with implementation of compliant systems.
- Working knowledge of Microsoft Office programs (e.g. Word, Excel, Access, and PowerPoint).
- Experience leading improvement projects.
