Computer Software Assurance Supervisor (34284)
About The Position
The CSA Supervisor facilitates and governs Computer Software Assurance (CSA) activities across regulatory and quality management systems in a regulated medical device environment. As a key driver of process improvement, the CSA Supervisor identifies opportunities to streamline quality software validation practices, enhance system usability, and reduce compliance risk with respect to software applications. This role ensures software systems are implemented and maintained in compliance with FDA, ISO, and global regulatory requirements using risk-based CSA methodologies. Exercises discretion and independent judgement related, but not limited to, adverse event and the quality management system.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field.
- 5+ years of experience in software validation, CSA, or CSV within the medical device or life sciences industry.
- Proven experience managing cross-functional projects in a regulated environment.
- Strong knowledge of FDA regulations, ISO standards (13485 preferred), and CSA methodologies.
- Excellent organizational, communication, and leadership skills.
- Typing/computer keyboard
- Utilize computer software (specified above)
- Retrieve and compile information
- Verify data and information
- Organize and prioritize information/tasks
- Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs)
- Verbal communication
- Written communication
- Leadership and supervisory, managing people
Nice To Haves
- PMP, or similar project Management certification, or Project Management experience
- 3+ years Experience with Agile, or hybrid SDLC methodologies
- Strong interpersonal skills with the ability to effectively communicate (written and verbal) at all levels internally as well as externally
- Utmost respect for confidentiality
- Extreme attention-to-detail
- Excellent organizational skills
- Ability to properly manage time and multiple priorities
- Strong ability for problem solving, adaptability, and flexibility
- High level of customer service with a positive attitude
- Ability to retrieve and interpret documentation
- Ability to work in a team setting and independently under minimum supervision
- Exercises good judgment
Responsibilities
- Facilitates and governs CSA validation activities.
- Lead risk assessments, including review of URS/FRS, to determine appropriate CSA strategies for new and existing systems
- Maintains validation documentation, and ensures regulatory compliance (test protocols, traceability matrices).
- Ensure alignment with CSA principles, identify opportunities to simplify validation activities while maintaining compliance.
- Partner with IT, Operations, and Manufacturing departments to ensure CSA activities support business and compliance needs.
- Collaborate with stakeholders to optimize system implementation and change control processes
- Facilitate stakeholder engagement and communication throughout the software lifecycle.
- Support change control processes and system upgrades with appropriate CSA documentation
- Identify opportunities to streamline CSA processes and improve system usability and compliance.
- Develop and deliver CSA training and guidance to internal teams.
- Track and report CSA project metrics and KPIs to leadership.
Benefits
- competitive benefits package
- paid parental leave
- In-house training and professional development opportunities
- A culture of creativity and innovation by drawing on diverse perspectives and ideas to drive surgical innovation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
501-1,000 employees
