Location: Lakewood, CO
Salary: $85,000.00 USD Annually - $105,000.00 USD Annually
Description:
Title: QA Engineer
Location: Lakewood, CO
Hybrid: Yes
Employment Type: Full-Time
Contact: Ryan Griffin:
About the Role
We are seeking a detail-oriented Software Quality Analyst to support software validation across our Quality Management System (QMS) and Product Lifecycle Management (PLM) processes. In this role, you will execute validation testing, develop documentation, and ensure our software releases meet regulatory and audit-ready standards. You will also become a subject matter expert in PTC Windchill and play a key role in delivering production-ready code.
Responsibilities
Execute software validation and testing activities in alignment with QMS/PLM procedures.
Develop user requirements, functional requirements, test plans, test procedures, and test scripts.
Become highly proficient in the Windchill application and its functional workflows.
Collaborate with cross-functional teams to ensure on-time delivery of validated software.
Analyze and troubleshoot technical issues; propose structured solutions.
Maintain complete, accurate, and audit-ready validation documentation.
Support requirements gathering and business analyst tasks as needed.
Uphold process discipline and contribute to departmental productivity.
Minimum Qualifications
Bachelor's degree in Computer Science or related field, or equivalent experience.
2+ years of experience in software validation or software quality assurance.
Familiarity with GMP, GAMP 5, IEEE, or ISO 9000 standards and software traceability.
Strong documentation skills (requirements, test scripts, deviation reports, validation summaries).
High attention to detail and ability to follow structured validation programs.
Strong verbal and written communication skills; confident voice in team settings.
Ability to manage deadlines and work independently with minimal supervision.
Working knowledge of FDA 21 CFR Part 11 or similar regulatory requirements.
Proficiency with PC applications relevant to documentation and testing.
Preferred Qualifications
Experience validating PTC Windchill v11 or v12.
Experience assisting with business analysis and requirements gathering.
Demonstrated ability to implement and maintain process discipline.
Background supporting validation efforts in regulated or life-sciences environments.
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Contact:
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Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: cxjudgpa
- Position Id: 1120221
- Posted 14 hours ago
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