Sr. Quality Systems Software Validation Engineer

Overview

Develops and prepares requirements, protocols and reports for software system validation work. Designs, develops and modifies software systems using Software Development Life Cycle to predict and measure outcome and consequences of design.   Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Frequent use and application of technical standards, principles, theories, concepts and techniques. Provide solutions to a variety of technical problems of moderate scope and complexity.

What you’ll do:

• Maintain and enhance Quality Records utilizing Structured Query Language (SQL) and  other programming language programs.
• Develop and direct software validation tests and procedures of new and existing systems.
• Modify Access Database software systems to fit specific user needs and workstations, and document methods used and various test cases.
• Create and develop system reports utilizing SQL query. Confer with programmers and analysts in defining product requirements in order to identify test scenarios and performance limits.
• Analyze database design in the planning, development, implementation and maintenance of software applications and design mitigation strategies and contingency processes.
• Design software validation plans and perform software validation tests of new and existing systems and document methodologies for test cases.
• Store, retrieve, and track the resolution of software data, defects, and system capabilities.
• Participate in Change Control process, revising test specifications and test protocols to implement changes to determine adequacy and correctness, and validate changes to ensure that changes are correctly incorporated in the software products.
• Coordinate software system installation and create reports on status of systems.
• Utilize SQL, Oracle 10g, Visual Basic and Visual Basic Scripting Edition (VBScript), and BarTender and Loftware softwares to design and create automated labels from database systems.
• Participates in the management of computerized Quality Systems.  Participates in the improvement of computerized Quality Systems validation practices and procedures.
• Maintains competence in regulatory requirements and industry trends for computerized system validation (ISO 13485, 21 CFR 820, 21 CFR Part 11, GAMP-5).
• Tracks computerize Quality System validation projects metrics and identifies areas for improvement. 
• Assist project managers by providing the portfolio of validation projects. 

What you bring to the team:

Further Education

• BS in Computer Science

Nice to Have

• MS in Computer Science

Work Experience

• Minimum 3 - 5 years’ experience writing SQL/ Oracle queries, functions and procedures, VB Scripting and technical documentation for complex activities.  This experience should be in the areas of validation of quality system or product development in a pharmaceutical or medical products environment, and should include a minimum of three years in software validation role

Personal Competencies

• Ability to communicate effectively, verbally and in writing

Social Competencies

• Demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.

Leadership Competencies

• Solid organizational and planning skills

Professional Competencies

• Strong understanding of global medical device regulations with proven experience with ISO 13485 and 21 CFR 820.

Language(s)/ Level

• Fluent English

IT Skills

• Visual Basic and Visual Basic Scripting Edition (VBScript) – The various software systems used in Advanced Bionics requires programming code to perform required functionality like reading from the
• SQL/Oracle database, reporting functions in MS Access
• SQL and Oracle 10g – To read/write data into the database systems and create reports, queries, views and integrate with the software systems
• Software Validation and Software Debugging – Validate changes made to the software systems and document the results after implementing the various test scenarios to verify that the changes made are accurate

Our offer:

• Exciting and challenging work environment
• Comprehensive benefits package
• Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us!

Don't meet all the criteria?  If you’re willing to go all in and learn we'd love to hear from you! 

We love to work with great people and strongly believe that a diverse team makes us better.  We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.

We thank all applicants in advance; however only individuals selected for an interview will be contacted.  All applications will be kept confidential. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Senior Manager, Human Resources.