Senior Software Quality Engineer
Why Join ACIST?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference......every day!
This position supports the development, validation, implementation, and maintenance of product software. With the software team, owns and maintains processes to appropriately control and validate product software. Oversees and manages validation activities and documentation, including risk files, software requirements and specifications, verification / validation plans and reports, and other software related documents. Supports the development and implementation of cybersecurity requirements and collaborates with cross-functional team on continuous improvement initiatives.
Primary Duties and Responsibilities:
Product Quality Software
- 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 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.
- Lead Software Lifecycle Training as it applies to internal and external regulatory processes.
Qualifications (Knowledge, Skills & Abilities):
- 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 validation in a medical device environment
- Experience with PLM, ERP and other QMS applications
- 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
- Experience with cybersecurity and knowledgeable in HIPAA regulations and GDPR and related data protection policies
- Demonstrated knowledge and proficiency in the application of 21 CFR Part 11, IPSE GAMP, 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
- Effective technical writing skills
- Ability to work independently with minimal oversight
- Ability to travel both domestically and internationally
- Travel expected to be approximately 10-15%
- Advanced degree in Computer Science, Software Engineering, or similar discipline
- ASQ CSQE (Certified Software Quality Engineer) or similar certification
- Experience with Agile PLM, Jama, TrackWise and/or SAP
- Demonstrated project management skills
- Familiarity with SDLC processes and methodologies, especially the application of Agile methods in the development of medical device software