Validation Engineer, Medical Devices – Austin

Flex; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Flex is seeking a Validation Engineer in Austin, TX to lead validation and QA oversight for medical device manufacturing. You will develop and review validation plans, protocols, risk assessments, and summary reports while ensuring CFR Part 820/11 and ISO 13485 compliance.

Role requires 6+ years in quality/validation, strong communication, and ability to work independently in a 24/7 environment. On-site posting with opportunities to influence product assurance programs and audits.

Qualifications

• Bachelor's degree in engineering or related field or equivalent experience and training.
• 6 years of Quality/ Validation experience.
• Prior process and/or facilities validation experience in medical device/pharma/biotech with CFR Part 820, Part 11, ISO 13485, Annex 11, ISO9001.
• Working knowledge of process, facilities validations and GAMP standards.
• Experience generating, reviewing and approving validation deliverables, statistical analysis, risk management, incident and change management.
• Experience in a prior quality assurance role and ability to work independently with minimal supervision.
• Excellent communication, organizational, project management and decision-making skills.
• Experience in 24/7 operations environment strongly preferred.

Responsibilities

• Guide and support the validation team, provide validation and QA oversight on process/facilities validation and qualification activities to ensure compliance and recommend corrective actions.
• Ensure validation policies and procedures are implemented and followed for medical device manufacturing.
• Implement and coordinate product assurance programs to prevent or eliminate defects in new or existing products.
• Research, evaluate and present information on business situations, production capabilities, manufacturing problems, and design and development of new products.
• Suggest and debate alternative methods and procedures to meet business needs and changing market opportunities.
• Collaborate with management to formulate and establish company policies, procedures and goals.
• Develop initial and subsequent modifications of product assurance program to delineate areas of control and procedures.
• Interface with customers on technical/quality issues and improvement initiatives.
• Manage regulatory/compliance audits as SME for the area/ process.
• Review technical problems and procedures and recommend solutions to improve QA systems.
• Implement validation controls across manufacturing areas per policies.
• Author, review and approve validation deliverables (plans, protocols, risk assessments, traceability, reports).
• Monitor validation deliverables/activities to ensure compliance and complete documentation.
• Support other validation areas as needed.

Skills

Quality/Validation

Process validation

Regulatory knowledge

Communication

Project management

Independent work

24/7 operations experience

Education

Bachelor's degree in engineering

Tools

GAMP standards

Job description

Flex is seeking a Validation Engineer in Austin, TX to lead validation and QA oversight for medical device manufacturing. You will develop and review validation plans, protocols, risk assessments, and summary reports while ensuring CFR Part 820/11 and ISO 13485 compliance.

Role requires 6+ years in quality/validation, strong communication, and ability to work independently in a 24/7 environment. On-site posting with opportunities to influence product assurance programs and audits.