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Job Summary
Summary
The “Quality Engineer” will be based in Austin, Texas, reporting to
Sushanth Mothukuri.
What a typical day looks like:
In this role, you will be responsible for ensuring that software systems developed, implemented, and used within medical device manufacturing operations are appropriately planned, verified, validated, controlled, and maintained in compliance with Flex Quality System requirements and applicable regulatory standards.
The experience we’re looking to add to our team:
- Provide Quality and Validation oversight for software verification and validation activities to ensure compliance with internal procedures, customer requirements, and applicable regulatory standards.
- Ensure software validation policies, procedures, and lifecycle requirements are effectively implemented and maintained from system planning through retirement for non-product software systems supporting medical device manufacturing operations.
- Executes and manages software validation and control activities. Author, review, approve, and manage software validation deliverables, including:
- Validation Plans
- User Requirements Specifications (URS)
- Functional and Design Specifications
- Risk Assessments
- Test Plans, Protocols, and Reports
- Traceability Matrices
- Validation Summary Reports
- Change and Release Documentation
- Monitor validation projects and deliverables to ensure adherence to approved methodologies, validation strategies, documentation requirements, and project timelines.
- Assess software changes, incidents, deviations, and nonconformances to determine validation impact and ensure appropriate actions are implemented.
- Partner with cross-functional teams including IT, Engineering, Manufacturing, Quality, and external customers to support software implementation and validation activities.
- Serve as the Quality representative during computerized system deployments, upgrades, maintenance activities, and retirement processes.
- Support customer, internal, and regulatory audits and inspections by providing software validation documentation, evidence, and compliance expertise.
- Review technical issues and quality system processes and recommend improvements to strengthen compliance, efficiency, and effectiveness.
- Drive and maintain software control practices including change management, access management, data integrity, backup/recovery, and periodic review activities.
- Support risk management activities and ensure appropriate mitigation measures are implemented and documented.
- Contribute to the development and continuous improvement of software validation procedures, templates, and best practices.
- Support process validation, equipment qualification, and other validation activities as required to meet business objectives.
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- Bachelor’s degree in engineering, Computer Science, Life Sciences, Quality, or a related technical discipline.
- Minimum 5 years of experience in Computer System Validation (CSV), Software Validation, or Software Quality within a regulated industry.
- Previous experience supporting medical device, pharmaceutical, biotechnology, or other FDA-regulated environments.
- Strong knowledge of FDA 21 CFR Part 820, FDA 21 CFR Part 11, EU Annex 11, ISO 13485, GAMP 5and Risk-Based Validation Methodologies
- Thorough understanding of Software Development Life Cycle (SDLC) processes and computerized system validation principles.
- Experience reviewing and approving SDLC documentation and validation deliverables.
- Knowledge of Change Management, Incident Management, Configuration Management, Risk Management, Data Integrity Requirements.
- Experience with Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, Quality Management Systems (QMS), and other manufacturing software platforms.
- Familiarity with cloud-based systems and cybersecurity controls is a plus.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent communication and interpersonal skills.
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Self-motivated with the ability to work independently and collaborate across cross-functional teams.
- Strong organizational and project management skills.
What you'll receive for the great work you provide:
- Full range of medical, dental, and vision plans
- Life Insurance
- Short-term and Long-term Disability
- Matching 401(k) Contributions
- Vacation and Paid Sick Time
- Tuition Reimbursement
Application Deadline:
Applications for this job position will be accepted for at least five days following the job posting start date below and continuing until the end date below or until the position is filled. This posting may close sooner due to application volume.
Job Category
Quality
Is Sponsorship Available?
No
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).