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Compliance Engineer

Expired Job

Idexx Laboratories, Inc. Westbrook , ME 04092

Posted 2 months ago

* Performs engineering activities to identify quality suppliers and parts for Company products. Act as lead technical interface between Company and supply base. Identifies Critical to Quality (CTQ) components and production processes necessary for supplier to deliver a quality part. Interprets design drawings and specifications, provides coaching and guidance and ensures suppliers have sufficient processes in place to meet CTQ items. Assists suppliers in implementing new processes as needed for compliance. Reviews and approves supplier quality control plans detailing each step of the manufacturing process. Applies Statistical Process Control (SPC) techniques to CTQ items to ensure part quality. Works in teams with supplier relationship managers, research & development (R&D) and others. Critiques R&D design specifications and other engineering protocols from supplier perspective, arranges R&D/supplier meetings and partners with R&D through to product launches.PRIMARY DUTIES AND RESPONSIBILITIES:*
  • Performs engineering activities to identify quality suppliers and parts for Company products. Acts as engineering contact to assigned supplier(s). Develops and recommends suppliers, equipment, tools and resources required for Company products. * Identifies Critical to Quality (CTQ) components and production processes necessary for suppliers to deliver quality parts. Initiates and communicates performance measures to worldwide supply network members. * Interprets design drawings and specifications, provides coaching and guidance and ensures suppliers have sufficient processes in place to meet CTQ items. * Reviews and approves supplier quality control plans detailing each step of the manufacturing process. Develops, implements and manages incoming quality assurance, sampling plans, inspection tools and custom measurement equipment. * Assists suppliers in implementing new processes as needed for compliance. Manage part or product quotations, process definition and development, custom tooling costing/scheduling/implementation and production start up ending in supplier qualifications to self developed schedules. * Develops and implements the documentation, process operations and qualification steps that support supplier production operations. Performs day to day problem solving and debugging using Six Sigma tools and methodologies. Manages supplier corrective actions and lead activities to improve supplier performance. Define, analyze and implement part and end product transfers. * Applies Statistical Process Control (SPC) techniques to CTQ items to ensure part quality. * Provides product data (specifications, drawings, bills of materials, testing requirements, etc.) to the supplier for purposes of review prior to the implementation of a Change Order (CO) ensuring that suppliers are in the CO review process and capable of adhering to the required CTQ's. * Develops strong business relationships and works in teams with supplier relationship managers, research & development (R&D) and others. Leads supplier process assessments for new and existing suppliers. * Critiques R&D design specifications and other engineering protocols from supplier perspective, arranges R&D/supplier meetings and partners with R&D through to product launches. Provides leadership with internal R&D engineering for supplier and part/product qualification and change management during the part and product definition, development, prototyping, pilot production and design verification process. Responsible for part and product introduction. * Develops capital and expense budgets and manages yearly budget spending on assigned projects.EDUCATION:* Bachelors degree or equivalent combination of education and experience required.REQUIRED SKILLS AND ABILITIES:* Ability to write reports, business correspondence, and procedure manuals. * Ability to effectively present information and respond to questions. * Ability to work with mathematical concepts. * Ability to calculate production cycle time, labor standard, efficiency/effectively/utilization and staffing models. * Ability to generate, interpret, and explain with clarity, complex mechanical design drawings and documentation. * Ability to adapt formal problem solving methodology to fit the situation discovered. * Mastery of or capable to perform engineering and non-engineering applications. * Project leadership/management skills. * Production assembly and test process flow design and implementation. * Product and process control skills * Must be able to perform well both autonomously and in leading teams.PHYSICAL DEMANDS:* Extensive sitting, standing and computer use. * Extend and reach with hands and arms and use hands and fingers. * Occasionally required to climb, balance, bend, stoop, kneel or crouch. * May be required to lift, move and carry up to 50 pounds. * Some travel required. * Work with exposed moving electro-mechanical parts. * Work with exposed electrical power requiring proper protective equipment.WORK ENVIRONMENT:* Office, engineering lab and industrial environments requiring safety, electrostatic discharge (ESD), clean room and other equipment. Additional work with electrical solder and fluxes, exposure to supplier assembly processes using chemicals, with machinery noise.LEVELING GUIDE:* Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. * Networks with senior internal and external personnel in own area of expertise. * Ability to generate written reports and verbal presentations to LOB and Executive Management, with strong report writing and presentation skills. Can communicate effectively to a broad audience or one-on-one. Has built a small established network of internal and external resources. * Performs work with no direct supervision. Normally receives little instructions on day-to-day work, general instructions on new assignments. Provides guidance and basic coaching and mentoring to junior Engineering-level employees. May supervise others. * Leads project teams that may cross multiple disciplines within a functional organization. * Solves complex problems or problems that do not have routine solutions; takes a new perspective using existing solutions. May lead multi-disciplined problem solving team. * Typically 5+ Years Experience. * Mentors junior R&D engineers in areas such as part selection. * Mentors manufacturing on appropriate processes. * Leads/participates in cross-functional teams. * Experience in a bio-tech industry preferred. * Experience in a automated manufacturing environment preferred, including GAMP. * Basic computer skills in advanced applications (Access, Powerpoint, JMP, etc.). * Manages cost center spending within budgeting process. Maintains complex project spending. * Experience developing processes and participating in audits in a regulated environment. * Lead candidate identified*
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    Compliance Engineer

    Expired Job

    Idexx Laboratories, Inc.