Sr Quality Engineer

Job Title: Sr Quality Engineer

Location: Austin, Texas

Job Description

Prepare Work Instructions for the day-to-day activities pertaining to the applications and underlying systems quality review process.

Ensure knowledge pertaining to new implementations and technologies is adequately shared with the team.

Ensure adequate monitoring and controls are in place to ensure the stability of the solutions.

Establish clear communication channels and ensure proper feedback mechanisms are in place with all stakeholders and cross-functional teams.

Support to complete all the required CSV deliverables

Ensure and coordinates the proper execution of all CSV activities.

Provides independent review and approval of all CSV deliverables generated during the Software Verification and Validation.

Reviews test case with trace matrix and ensures adequate test coverage to challenge the functionality and to determine if the proposed testing would achieve the purpose.

A review of executed protocols and reports for adherence with GDP and validation practices, and to determine if the conclusions drawn in the reports are justified.

Review the impact analysis and resolution provided in incidents/defects.

Support to identify and forecast the risk and issue with an appropriate solution.

Knowledge of the Change Management process

Experienced in corrective and preventive actions (CAPA).

Must Haves:

5+ years of experience with Medical Device/Pharmaceutical organizations in software quality engineering capacity

Must have knowledge of IT environments and how to maintain applications

Must have in-depth knowledge of 21CFR Part 11, 21CFCR Part 820 and ISO13485 regulations

Outstanding oral and written communication skills with high attention to detail in the review process

Experience in test management tools

Experience in the usage of DocuSign

Reach me at chaitanya@starkassociatesllc.com (or)

Contact; +1 (848)277-1023