Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.

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.

Job Summary

• Well verse in GMP procedures and validation requirements and experience at gathering technical information from vendors and scientific literature
• Serves as the validation coordinator on selected project teams.
• Ensures validation including protocols and reports compliance to site requirements and all applicable ISO 13485, FDA Quality System Regulation, cGMP requirements and any other applicable regulations.
• Develop validation master plan and validation protocols (IQ/OQ/PQ), write test scripts and lead process validation activities for various manufacturing processes
• Assists in the review and validation of process changes including protocols and report for completeness, accuracy and compliance to the site requirements, FDA Quality System Regulation, and ISO 13485 Standard.
• Interface with all medical customers to provide Flex Medical and Site compliance on validation overview including equipment qualification, change control.
• Assists to ensure a GMP compliance culture, and auditing program including corrective action process.
• Assess change controls, facility work orders and equipment risk assessments to ensure compliant/validate state of all GMP equipment and systems
• Ensures that validation activities, protocol, report, and execution are being carried out in compliance to site and regulatory requirements.
• Perform deviation investigations and help to implement CAPA and re-validation as necessary

• Possesses a Degree in related discipline or equivalent experience.
• Minimum 5 years of working experience in the related field is required

• Develops and initiates standards and methods for inspection, testing and evaluation.
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data.
• Develops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost.
• Directs workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability.
• Compiles and writes training material and conducts training sessions on quality control activities.
• Holds up Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues.
• 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.
• 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.
• Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
• Explores reports and returned products and recommends corrective action.
• Establishes program to evaluate precision and accuracy of production equipment and testing, measurement and research of equipment and facilities.
• Approves product, process and equipment qualifications.
• Provides liaison to various regulatory bodies.

• Typically requires a Bachelor's degree in related field or equivalent experience.
• Typically requires 4 years of experience in engineering in the high technology electronics industry or related field.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations.
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.
• Use of the following tools may be required:
• Electronic Assembly: color code, component, schematics. May require various PCB operations.
• Testing: oscilloscope, cable and harness testing, trouble shooting, component testing, logic analyzer.
• Inspection: bare board, systems, components, cable and harness, microscope, measuring tools.
• Mechanical & Electrical Tools: taps and dies, alignment tools, measuring tools. Office skills: telephones, data entry, office software to include, word processing, spreadsheet and presentation package.
• Demonstrates operations and technical skills and understanding of Flex's functional standards.
• Demonstrates working knowledge of functional concepts and a solid understanding of Flex policies and procedures. Typically requires some knowledge of computerized electronic test equipment and programming.
• Demonstrates advanced functional and technical skills and basic process skills. Demonstrates advanced/thorough knowledge of the function and Flex business.
• Typically requires skill and troubleshooting, and diagnostics, and overview of the entire test process and the ability to train others.