Overview
On Site
Full Time
Skills
Risk Assessment
Risk Analysis
Science
Design Controls
ISO 9000
Analytical Skill
Document Management
Problem Solving
Conflict Resolution
Communication
Medical Devices
ROOT
Management
Change Management
Job Details
Responsibilities:
- The basic function of this position is to author technical change assessment related to medical devices and to provide support to customer complaints - including ensuring the root cause appropriately.
- Consider the device and device constituents, author technical and risk assessments related to the device design change, and document the device risk analysis from complaints.
- Team supports multiple Medical Device and Combination Products (MDCP), such as vaccine prefilled syringes and devices.
- Bachelor's in science, Engineering or related field. Can be a mix of Co-op and real-world experience (3-5+ years).
- Has experience in authoring design control documentations per 21 CFR 820.30 or device risk document per ISO 14971.
- Demonstrated interpersonal skills including flexibility and ability to work in a team environment. Proven analytical abilities.
- Work requires experience in engineering change assessment, root cause investigations and device risk document management.
- The candidate will work with a small team that supports life-cycle management activities of medical device combination products.
- Demonstrated interpersonal skills including flexibility and ability to work in a team environment. Proven problem-solving abilities.
- Demonstrated written and verbal communication skills.
- Preferred skillsets- Medical device combination product background/experience, understanding root cause, deviation management and change management.
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