Responsible for Quality Assurance and Quality Engineering activities throughout Quality Management System and Software Lifecycle. This includes ensuring that the quality management system and software lifecycle processes are compliant with applicable standards, regulations and guidance documents for medical devices and GxP computerized systems. The ability to effectively communicate applicable regulations, optimize the quality management process, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position. This position is part-time to start with the potential to go full time.
Guide design control and software development initiatives to develop appropriate Design History File documents for medical devices in accordance with FDA and EU regulations
Establish and maintain software quality assurance programs, processes, procedures and controls to ensure compliance with FDA and EU regulations, and established standards such as IEC 62304
Ensure compliance to IEC 62304, FDA, and EU Guidance on Software Contained in a 510(k) or EU MDR/IVDR submissions
Guide Risk Management Activities in compliance with ISO14971 and software risk requirements in IEC 62304
Support efforts for cybersecurity and data privacy risk management for both US and EU requirements
Provide guidance for the generation, review and approval of design control documentation with primary focus on software development deliverables
Provide expertise and participation in establishing planning documentation, software requirements analysis and tracing, risk file, specifications, detailed design, design and code reviews, verification and validation activities, defect tracking and configuration management
Collaborate with Project Management to support and optimize the design control and software lifecycle processes
Assist to develop and deliver design control training for software development organization
Work with software, hardware, user experience, marketing, manufacturing, and quality assurance on generation documentation, verification and validation of applicable QMS requirements such as ISO 13485
Support quality management system on the validation of quality system software
Assist with the execution of validation testing for computerized systems that are used as part of production processes or in the quality system.
Basic Qualifications
Strong accuracy and attention to detail
Excellent verbal and written communication skills
Ability to organize and prioritize multiple tasks in a timely manner
Professional attitude and demeanor
Strong service attitude and relationship building skills
Experience in Windows, including Word, Outlook and PowerPoint
Intellectual curiosity and a drive to learn and grow
Motivated self-starter
Superior follow up skills and transparency of work being delayed
Detail oriented and organized
Skilled in written and verbal communication
Highly responsive
Education and Experience
ASQ, CSQE or other software quality certificates are beneficial
BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience
Experience with medical device quality management system and software lifecycle
Working knowledge of the Quality System Regulation (FDA 21 CFR Part 11 and Part 820), EU Medical Device Regulation, and ISO 13485 quality system standards
Experience with a risk-based approach to validate computerized systems and software tools
Experience with cloud based systems and cybersecurity
A minimum of 10 years work experience in Software Quality Engineering within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
Experience in the development and implementation of effective quality management systems
Working knowledge of IEC 62304, ISO 14971, IEC 62366, and FDA guidance documents on software development, cybersecurity, and submission requirements for PMA and 510(k)
Experience with software development methodologies such as Waterfall and Agile
Familiarity with data privacy regulations such as HIPAA and GDPR
Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.)
Demonstrated experience organizing and maintaining large documentation sets
Physical Requirements
Prolonged periods sitting at a desk and working on a computer.
About Beanstock Ventures:
BeanStock Ventures is a virtual, project-based software development and investment company. We are focused on improving lives by directly and indirectly supporting the development and delivery of innovative healthcare related products and services. BeanStock Ventures provides 20 years of regulatory and software development experience in various healthcare specific domains including but not limited to NGS, diagnostics, the point of care, critical care, laboratory, automation, workflows, and connectivity.
