Job Posting Start Date 11-14-2024 Job Posting End Date 01-27-2025
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We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives.
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.
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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 Columbia, SC.
Reporting to the Quality Manager , the Quality Engineer independently performs quality and validation activities, as well as manages environmental controls for a Class 8 Cleanroom to ensure that all requirements are effectively met. The Quality Engineer also will support in maintaining quality engineering programs, standards, and improvements within the organization.
What a typical day looks like:
- Collect, manage, analyze, and interpret complex scientific data from multiple sources to support Quality System metric reporting and production process technology
- Provides support to operations and engineering in developing statistical rationales, modes, acceptance criteria, sampling plans and statistical analysis to support the issuance of reports, dashboards, etc. in the identification of trends/out of trend and process improvements.
- Collaborate with cross-functional teams and subject matter experts (SMEs)to deliver data and report development.
- Responsible for reporting of yields, Critical Quality Attributes (CQA), measurement of product and process, non-conforming material report (NCMR), CAPA performance etc. to management and customers
- Supports risk assessment documentation development
- Develops forms and instructions for recording, evaluating and reporting quality and reliability data through a combination of coding and non-coding tools.
- Supports the Customer Focus Team (CFT) with customer interfaces as necessary on quality related issues.
- Compile clean data sets, modeling data, and analyze statistical data
- Develop and maintain proceduralized instructions for standard report generation
- Partner with IT to develop report automation and with Validation to assure validated reports when required
- Assures data availability and integrity for all quality related data. Consolidates and reports quality results.
- Initiates corrective action requests as needed and tracks to satisfactory completion.
- Promote regular communication of Customer requirements to Operation Leads
- Ensure ongoing compliance with quality and industry regulatory requirements
- Develop and carry out any Quality related training required within their area of expertise
- Participate in special projects and continuous improvement projects as required by management
- Process priorities in a timely manner
- Support Internal and External audit activity
- Additional tasks as assigned
- Typically requires a bachelor's degree in related field or equivalent experience.
- 4 years of quality engineering experience.
- 2 years of medical device manufacturing experience in a clean room environment required (ISO13485)
- Experience with CAPAs is required.
- Statistician or statistical data analyst experience
- Experience with validation ( plus)
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- PTO
- Tuition Reimbur
Design, Process & Technology Engineering
Is Sponsorship Available?
No
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and 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).