Software Quality Engineer

The Software Quality Engineer can heavily influence the company's compliance with Quality System regulations and standards relating to software. The Software Quality Engineer can approve software design and development documents such as those to be included in project Design History Files (DHFs) as a representative of Quality Assurance such as Test Plans and System Requirements documents. The Software Quality Engineer may also respond to requests for information and documentation required for regulatory filings and registrations or requests from suppliers.

The responsibilities of this position include, but may not be limited to the following:

• Manages Software Intended Use Validation (SIUV) projects and follows the SIUV procedure to ensure successful, on-time system releases.
• Completes software quality impact and risk assessment documentation with System Owners.
• Creates user and system requirements for the Strategy and Plan document as well as test cases for the Validation Protocol documentation.
• Creates Requirements Traceability Matrix and Final Report documentation.
• Develops, applies, revises, and maintains quality standards for software systems the company develops, including but not limited to manufacturing, engineering, and quality processes.
• Participates in New Product Development (NPD) design review, design control, and related activities, regarding software systems used in manufacturing, inspection and test, process control, and Quality Systems.
• Supports internal audits of quality management functions, processes, and procedures with regard to software and over which the Software Quality Engineer has no direct control or responsibility.
• Provides guidance, support, and training to other departments with regard to Software Quality Engineering including test documentation in support of Federal requirements.
• Establishing, monitoring, and complying with annual departmental budget requirements.
• Other duties as assigned.

The ideal candidate for this position will possess the following qualifications:

• Associates Degree required; Bachelor degree preferred
• ASQ/AAMI or equivalent certifications preferred
• Project management and software design and life cycle development experience required
• Two (2) years experience in a medical device (U.S. FDA-regulated and registered) Manufacturer or Specification Developer environment in a Software Quality Assurance role beneficial

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.