Software Quality Engineer

flex; Austin (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in manufacturing seeks a Software Quality Engineer to oversee software validation for medical device manufacturing. The role involves ensuring compliance with policies and regulatory requirements while providing QA oversight. Ideal candidates have extensive experience in the electronics industry, including knowledge of relevant regulations and a commitment to quality assurance.

Benefits

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

Qualifications

• 6 years in high technology electronics or related field.
• Prior software validation experience in medical devices.
• Knowledge of CFR Part 820, ISO 13485, and SDLC.

Responsibilities

• Ensure software meets Flex’s internal policies and regulatory standards.
• Manage software validation activities for medical device manufacturing.
• Interface with customers on technical/quality issues.

Skills

Software validation

Regulatory compliance

Risk assessment

Education

Bachelor’s degree in related field

Tools

MES systems

ERP systems

Job description

Job Posting Start Date 06-11-2025 Job Posting End Date 08-18-2025

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary. Job Summary

The Software Quality Engineer will be based in Austin, Tx, reporting to Quality Manager. In this role, you will be responsible for ensuring that the software developed and used for medical
device manufacturing process are appropriately developed, verified, validated to meet Flex’s internal policies, procedures and regulatory requirements

What a typical day looks like:

• Guide, support and provide validation and QA oversight on software validation/ verification activities to ensure compliance and recommend appropriate corrective actions as needed.
• Assure validation policies and procedures are implemented and followed from planning phase to the retirement phase for IT systems (non-product software) supporting medical device manufacturing.
• Executes and manages software validation and control activities by authoring, reviews, and approving software validation deliverables for non-product software systems, including but not limited to software validation plans, requirement test plans/protocols/results, risk assessments, traceability matrices, and summary reports.
• Monitor software validation deliverables and activities for assigned Non-product Software applications to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
• Suggests, debates alternative methods and procedures in solving problems to meet business needs and changing market opportunities.
• Contributes with other top management personnel in formulating and establishing company policies, operating procedures and goals.
• Interface with customers on technical/quality issues and improvement initiatives.
• Responsible for managing regulatory/compliance agency/customer audits by acting as an SME for the respective area / business process.
• Reviews technical problems and procedures and recommends solutions to improve and streamline the existing quality system processes.
• Implement practices around software control for all non-product software systems in line with applicable policies and procedures.
• Implements and coordinates product assurance program to prevent or eliminate defects in new or existing products.
• Additionally, required to support other areas of validation (process, facilities) as deemed necessary by business.

The experience we’re looking to add to our team:

• Typically requires a bachelor’s degree in related field or equivalent experience.
• 6 years of experience in engineering in the high technology electronics industry or related field.
• Prior software validation experience working in medical device, pharmaceutical or biotechnology industry with understanding of CFR Part 820, Part 11, ISO 13485, Annex 11.
• Working knowledge of software development life cycle (SDLC) and GAMP standards.
• Experience in generating, review and approval of SDLC deliverables, risk management, incident and change management.
• Knowledge of MES and ERP systems
• Prior supervisory, project management or process validation experience (prefer)

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

Job CategoryDesign, Process & Technology Engineering

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 [e-mail] 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).