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
Is Sponsorship Available?
NoFlex 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 [email protected] 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).Top Skills
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