The Senior Quality Engineer - Software can heavily influence the company''''s compliance with Quality System regulations and standards relating to software and associated areas such as process validation.
The Senior Quality Engineer - Software has the authority to implement company policy at the department level. Approve software design and development documents such as those to be included in project Design History Files (DHFs) as a representative of Quality Assurance. Order and direct internal audits as they relate to Quality System elements and software. Respond to requests for information or 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:
- 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
- Develops 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
- Support internal/supplier audits of quality management functions, processes, and procedures with regard to software and over which the Quality Engineer has no direct control or responsibility
- Support of other Quality Systems such as Corrective and Preventive Actions (CAPA), supplier corrective actions, and document control
- Provide technical guidance and training to other departments and quality personnel regarding Software QA Engineering areas of expertise
- Establishes, monitors, and complies with annual departmental budget requirements
- Two (2) years’ experience in a medical device (U.S. FDA-regulated and registered) Manufacturer preferred
- Specification Developer environment in Software Quality Engineering and/or Software Quality Assurance role required
- Advanced computer software and internet use (Specific languages, test cases, SV&V) proficiency as well as software design and life cycle development experience/knowledge required
- Bachelordegreerequired, Master''''s degreepreferred
- ASQ certification (e.g., Quality Manager, Engineer, Auditor) preferred.