QA Engineer -B-

Summary:

The role will be pulling and analyzing Complaint Data to support Risk Management / Postproduction Control. Responsible for planning, implementing, and managing compliance of post market monitoring processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.

Responsibilities:

1. Designs, implements, and maintains quality assurance protocols and methods for analyzing Complaint Data.
2. Designs methods and procedures for inspecting, testing, and evaluating the precision and accuracy of post-production processes.
3. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
4. Assures compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).
5. Applies concepts and principles to resolve a variety of issues.
6. Works on problems of a moderate scope where analysis of situation or data requires a review of a variety of factors.
7. Receives general instructions on routine work and detailed instructions on new projects or assignments.

Qualifications:

1. Professional degree in Engineering.
2. Must possess a minimum of 2 years of experience in an FDA Regulated environment (medical industry).
3. Fluent in English.