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.

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

Develops, applies, revises, and maintains quality standards for software applications and systems that the company develops in support of manufacturing, manufacturing engineering, or quality processes
Completes software test and software risk management policies and leads the activities associated with the software system risk assessment
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 Quality Engineer has no direct control or responsibility
Provides technical guidance and training to other departments with regard to Software Quality Engineering including test documentation in support of Federal requirements
Establishes, monitors, and complies 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
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.