Software Quality Engineer

Flex; Austin (TX); On-site; USD 105,000 - 185,000; Full time

Job summary

A leading company in diversified manufacturing is looking for a Software Quality Engineer in Austin, TX. The role involves ensuring software compliance in medical device manufacturing and requires extensive experience in software validation and quality assurance processes. Join Flex to contribute to innovation in a respectful and inclusive workplace.

Qualifications

• Typically requires bachelor's degree or equivalent experience.
• 6 years of experience in engineering in high technology electronics or related field.
• Prior software validation experience in medical device industry.

Responsibilities

• Guide and provide QA oversight on software validation activities.
• Execute and manage software validation activities and documentation.
• Monitor software validation deliverables to ensure compliance.

Skills

Software validation

Quality Assurance

Risk management

Incident management

Education

Bachelor's degree in related field

Tools

MES

ERP systems

Job description

Join to apply for the Software Quality Engineer role at Flex

Join to apply for the Software Quality Engineer role at Flex

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives. 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.

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)
• Site
  
  

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and 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).

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Industries

  Appliances, Electrical, and Electronics Manufacturing

Referrals increase your chances of interviewing at Flex by 2x

Get notified about new Software Quality Engineer jobs in Austin, TX.

QA Test Engineer, Software, Mobile Applications

Software Quality Assurance Tester Consultant for Texas Education Agency, Austin, Tx

Software Development Engineer in Test – 2025 (US)

Austin, TX $105,000.00-$185,000.00 1 week ago

Quality Assurance Engineer (Manufacturing)

Austin, TX $103,700.00-$129,700.00 9 hours ago

Crypto QA Engineer (Global-Remote-Non-US)

QA Engineer Automated 3 Consultant for Texas Education Agency, Austin, Tx

Senior Software Quality Assurance Engineer

Austin, TX $152,500.00-$262,350.00 2 weeks ago

Austin, TX $152,500.00-$262,350.00 2 weeks ago

Staff Software Test Engineer (Hybrid/Onsite)

Austin, TX $112,100.00-$162,600.00 1 day ago

Embedded Quality Assurance Engineer III, Quality Assurance, 3rd Eye

Austin, TX $120,000.00-$160,000.00 15 hours ago

Austin, Texas Metropolitan Area 3 days ago

Software Quality Assurance Engineer, Trilogy (Remote) - $60,000/year USD

Sr Software Development Engineer in Test (SDET)

AVP Software Development Engineer in Test

Austin, TX $115,000.00-$230,000.00 1 week ago

Software Development Engineer-Test, Amazon Customer Service

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.