Flex Software Quality Engineer 

United States, Texas, Austin 

308258386

Job Summary

Thewill be based in, reporting toIn 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 testplans/protocols/results,
• 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 managingregulatory/complianceagency/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

Design, Process & Technology Engineering