Quality Engineer

• 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.
• 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.
• 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.
• Working in accordance with deadlines for delivery of customer requirements.
• Implementing methods to inspect, test and evaluate the reliability of manufacturing processes, products and production equipment.
• Complete Corrective Action and Preventive Action (CAPA) tasks as assigned, and support other Quality Engineers in CAPA Coordination. Conduct and document investigations, participate in Root Cause Analysis, document corrective / preventive actions, document verification of effectiveness of corrective and/or preventive actions.
• Meet Key Performance Indicator (KPI) targets for NCRs, CAPAs, Training, and other site quality metrics.
• Supports Distribution Operations as assigned.
• Analyse current and future procedural needs of the business
• Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system
• Keep up with current and developing manufacturing and engineering trends that concern product quality
• Undertake special projects as required
• Write reports and present progress at project meetings and to clients
• Independently determine approach and assigned tasks
• Lead and/or support trainee engineers
• Communicate efficiently throughout the shop floor and with own and customer’s management

• 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.
• 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
• Certification as a lead auditor is considered an asset. o ASQ certification as a quality engineer is considered an asset.
• 2 years minimum’ experience operating in any Engineering position, preferably Quality Systems Engineering in a highly regulated environment (medical devices, biotech, pharmaceuticals, etc.) is optimal.
• Knowledge of 21 CFR Part 820 preferred, with knowledge of , ISO 13485, and any other medical device industry international standards a plus.
• Formal education developing problem solving skills, analytical skills. Specific tolls such as process mapping, histograms, FMEA, Cause and Effect Diagrams, etc. preferred.
• Able to work within a cross-functional team environment.
• Ability to work in a diverse and dynamic environment

• 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

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