Introduction
We are working with a medical device manufacturer seeking a Quality Manager to join their team out of the Nashua/Hudson area. You will be responsible for reviews and approves critical documents such as Device History Records, SOPs, Validation Protocols, Deviation Reports, and CAPA Reports to ensure operational support and compliance.
You will be responsible for
- Reviews and approves documents, including Device History Records, SOPs, Validation Protocols and Reports, Deviations, Change Requests, and Non-Conforming Materials Reports, CAPA Reports, and Complaint investigations to ensure operational support and compliance.
- Solve problems using Cause & Effect diagrams, PFMEA, Root Cause Analysis, etc.
- Perform Corrective Actions and Non-conformance assessments.
- Utilize project management strategy at a department level to successfully execute multiple projects with competing resources and prioritization.
You will bring the following
- BS in an engineering capacity or relevant work experience.
- 5 years in a management capacity OR 8 years in an engineering capacity leading projects.
- Experience in regulated, relevant environments (FDA 21 CFR Part 820, ISO 13485, ISO 14971, etc.).
- Cross-functionality will be expected for this role.
