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About the Role
The Validation Engineer will be responsible for ensuring that equipment developed and used for medical device manufacturing processes are appropriately developed, verified, and validated to meet Flex’s internal policies, procedures, and regulatory requirements.
Responsibilities
- Guide and support the validation team, providing validation and QA oversight on process/facilities validation and qualification activities.
- Recommend appropriate corrective actions as needed.
- Assure 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 concerning business situations, production capabilities, manufacturing problems, economic trends, and design and development of new products.
- Suggest and debate alternative methods and procedures in solving problems to meet business needs and changing market opportunities.
- Collaborate with other management personnel in formulating and establishing company policies, operating procedures, and goals.
- Develop initial and subsequent modifications of product assurance programs to delineate areas of control, personnel requirements, and operational procedures.
- Interface with customers on technical/quality issues and improvement initiatives.
- Manage regulatory/compliance agency/customer audits by acting as an SME for the respective area/business process.
- Review technical problems and procedures and recommend solutions to improve and streamline existing quality system processes.
- Implement practices around validation controls for all manufacturing areas in line with applicable policies and procedures.
- Execute and manage validation and control activities by authoring, reviewing, and approving validation deliverables, including validation plans, requirement test plans/protocols/results, risk assessments, traceability matrices, and summary reports.
- Monitor validation deliverables and activities for assigned areas to ensure regulations, protocols, procedures, and methodologies are followed.
- Ensure appropriate and complete documentation is captured and reported to support validation activities.
- Support other areas of validation as deemed necessary by business.
Requirements
- Typically requires a 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 working in medical device, pharmaceutical, or biotechnology industry.
- Understanding of CFR Part 820, Part 11, ISO 13485, Annex 11, ISO9001.
- Working knowledge of process, facilities validations and GAMP standards.
- Experience in generating, reviewing, and approval of validation deliverables, statistical analysis, risk management, incident and change management.
- Experience in a prior quality assurance role.
- Ability to work independently with minimal supervision.
- Excellent communication, organizational, project management, and decision-making skills.
- Experience working in a 24/7 operations environment strongly preferred.
Skills
- Validation
- Quality Assurance
- Process Validation
- Facilities Validation
- Medical Device Manufacturing
- Regulatory Compliance
- Product Assurance
- Risk Management
- Statistical Analysis
- Incident Management
- Change Management
- Project Management
- Communication
- Organization
- Decision-making
Location
- Austin, TX
Work Type
- Full-time
Experience Level
- 6 years of Quality/Validation experience
Education Level
- Bachelor's degree in engineering or related field or equivalent experience and training
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
About the Company
- 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.
Equal Opportunity
- 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).