Computer Software Assurance Supervisor (34284)

Job Summary

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.

Essential Functions, Duties, And 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.

Continuous Improvement

• 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.

Qualifications

• Educational and Experience 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.
• Knowledge, Skills, And Abilities:
  • 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.
  • 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.
• Skill Requirements:
  • 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.
• Physical Requirements:
  • Sitting for extended periods.
  • Extended periods viewing computer screen.
  • Walking.
  • Reading.
  • Speaking.
  • Hear/Listen.
  • Maintain regular, punctual attendance.
  • Writing.
• Hazards:
  • Normal office environment.
• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
• This role is not eligible for employer sponsorship of any kind.
• KLS Martin is a drug-free employer.