Senior Validation Engineer

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.

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Senior Validation Engineer located in Senai, Johor.

What a typical day looks like:

• 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
  
  

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

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

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Summary:

The “Quality Engineer” will be based in ……, reporting to …….

In this role, you will be maintaining quality engineering programs, standards and improvements within the organization.

Responsibilities:

• 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.
  
  

Qualifications:

• 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.
  
  

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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 [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).