Senior Software Quality & Validation Engineer
About The Position
The Senior Software Validation Quality Engineer supports and maintains the organization's software validation and Computerized Systems Assurance (CSA) program in a regulated medical device environment. The role provides guidance on software compliance, validation strategy, risk-based decision-making, and lifecycle management of computerized systems used throughout the product lifecycle and Quality Management System. It partners with Quality, Regulatory, Engineering, Operations, Manufacturing, and Information Technology teams across multiple sites to support compliance with applicable regulatory and quality requirements. The position is onsite five days a week and requires approximately 25% domestic and international travel. It focuses on software validation, quality systems, and regulatory compliance; it does not involve software development or coding.
Requirements
- Bachelor's degree in a technical, scientific, quality, or related discipline, or an equivalent combination of education and experience.
- At least 4 years of experience in a regulated industry, including experience supporting CSV, CSA, software validation, or related quality and compliance activities.
- Familiarity with FDA quality system regulations, electronic records requirements, and/or quality management system standards such as FDA 21 CFR Part 820, FDA 21 CFR Part 11, ISO 13485, or equivalent regulated-industry standards.
- Understanding of medical device product lifecycle processes and quality system requirements.
- Experience conducting software risk assessments, validation reviews, and change impact assessments.
- Experience authoring or reviewing validation plans, protocols, reports, and software risk assessments.
- Strong communication, collaboration, and technical writing skills.
- Ability to work onsite five days a week.
- Ability to travel approximately 25% domestically and internationally.
Nice To Haves
- Experience validating eQMS, ERP, MES, or manufacturing support software.
- Experience in the medical device, FDA-regulated, aerospace, or another regulated industry.
- CSQE or ISTQB certification.
Responsibilities
- Maintain and continuously improve the software validation and Computerized Systems Assurance (CSA) program.
- Provide guidance on software risk assessments, validation impact assessments, and risk-based validation strategies in accordance with CSV and CSA principles.
- Develop, review, and maintain validation plans, protocols, reports, and related documentation.
- Provide guidance on CSV and CSA approaches for computerized systems.
- Guide cross-functional teams on software validation requirements, risk assessments, and compliance expectations.
- Support validated QMS, ERP, manufacturing, laboratory, and business systems.
- Assess software changes, upgrades, and implementations for validation impact and revalidation requirements.
- Support internal, customer, certification, and regulatory audits related to software validation activities.
- Participate in CAPA, change management, and continuous improvement initiatives.
- Provide cross-functional support to Quality Systems activities as needed.
- Collaborate across global sites and functions.
Benefits
- Company-paid holidays and paid time off.
- Flexible working schedule through the paid time off policy.
- 401(k) plan with an employer matching contribution.
- Comprehensive health and wellness plans.
- Talent programs and opportunities for career development.
- Employee Resource Group, Employee Recognition, and 3D Gives Back programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
