Senior Software Quality Engineer
Come join a role with an established, growing medical device company as their Senior Software Quality Engineer!
This position supports the development, validation, implementation, and maintenance of medical device product software. With the software team, you’ll own and maintain processes to appropriately control and validate product software. You’ll oversee and manage validation activities and documentation, including risk files, software requirements and specifications, verification / validation plans and reports, and other software related documents. You’ll support the implementation of cybersecurity requirements and collaborate with the cross-functional team on continuous improvement initiatives.
Role & Responsibilities
- Implement and maintain processes and procedures to ensure that product software is constructed and validated according to the appropriate regulations and internal requirements.
- Support all aspects of product software, including software requirements, cybersecurity, verifications / validations, risk management, and other software related activities.
- Manage changes to product software, including use of change control tools and change impact analysis. Provide Quality support and approvals for implementation and changes to product applications.
- Support the assessment and management of vendors and outsourced services related to product software and associated validation.
- As subject matter expert (SME) for product software, maintain current knowledge of regulatory environment, standards, and regulations.
- Provide guidance and training to staff regarding software verification / validation requirements.
- Support internal and external audits as well as Regulatory requests related to product software.
- Support software development and integration into the Product Development Process.
- Partner with Product Quality Engineers to educate and drive deeper knowledge of Software and Lifecycle management.
Required Skills & Experience
- BS in Engineering, Computer Science, Information Systems, or similar discipline
- 5-7 years of experience in Product software applications, developer, analyst and/or QA
- 5+ years of experience with software in a medical device environment
- Experience with software development methodologies
- Strong working knowledge of the FDA Quality System Regulation, ISO 13485, the Medical Device Directive and Medical Device Regulations
- Knowledge and proficiency in the application of AAMI TIR 36, EN 62304, EN 62366, IEC/TR 80002-1, and other standards, regulations and guidance related to validation of software and computerized systems
- Knowledgeable in HIPAA regulations and GDPR and related data protection policies
- Demonstrated knowledge and proficiency in the application of 21 CFR Part 11, ISO 14971, and other standards, regulations and guidance related to validation of software computerized systems.
- Demonstrated knowledge and proficiency in quality principles and best practices
- Strong collaboration skills to effectively communicate with both business and technical teams
- Effective oral and written communication skills
- Ability to work independently with minimal oversight
- ASQ CSQE (Certified Software Quality Engineer) or similar certification pref.
- Experience with cybersecurity is a plus
- Experience with Agile PLM, Jama, TrackWise and/or SAP is a plus
- Familiarity with SDLC processes and methodologies
Versique is one of the largest recruiting firms in the Midwest and specializes in both consulting and permanent placement. With a valuable blend of functional, industry and recruiting experience, our award-winning team of headhunters has a proven track record of delivering exceptional talent acquisition solutions. The Versique brand represents a powerful combination of “versatile” and “unique” as it hints at the concept of “search” in it’s pronunciation: ver-seek.
Versique is an equal opportunity employer committed to creating a diverse workforce. We consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability, or veteran status, among other factors.