Quality Engineer

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Quality Engineer located in Austin, TX.

Reporting to the Quality Manager, the Quality Engineer role will be maintaining quality engineering programs, standards and improvements within the organization.

What a typical day looks like:

• Holds up Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues.
• Initiates corrective action requests as needed and tracks to satisfactory completion.
• Assists with development and implementation of quality audits.
• In charge of developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products.
• Explores reports and returned products and recommends corrective action.
• Provides liaison to various regulatory bodies.
• Support the site's Quality Compliance team to ensure the conformance of all organization's regulatory and quality systems requirements
• Verify compliance and conformance to all regulatory and quality systems requirements, including both Customer and Flex mandated
• Engage in External Audit Processes (Customers', Regulatory, Government Agencies, etc.)
• Verify the proper implementation and effectiveness of the applicable Regulations, Standards, Policies, Directives and Level 1 Procedures in the organization
• Provide support to any area that requires help to implement regulatory and quality requirements into their processes
• Follow up on internal and external corrective actions to ensure timely implementation.
• Supports developing and maintaining audit readiness programs
• Assess quality management system documentation to verify compliance and conformance to all regulatory and quality systems requirements, including both Customer and Flex mandated
• Based on the applicant/employee experience, the following activities may apply:
• Responsible for the management and tracking of Corrective and Preventive Actions related for company internal nonconformities/out-of-specification events and customer feedback/customer complaints received.
• Provides guidance and assistance to the support teams in identifying root causes of issues, developing strong containment, corrective and preventive actions as required
• Initiates corrective action requests as needed and tracks to satisfactory completion.
• Supports/performs investigations using quality investigation tools
• Act as a subject matter expert (SME) for root cause investigations
• Supports with customer communication to quality related topics or requests

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

• Typically requires a bachelor’s degree in engineering or equivalent experience and training.
• 2+ years of quality experience
• 2+ years of medical device industry experince/ ISO13485
• 2+ years QMS / compliance experience

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 Category

Is Sponsorship Available?