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Manufacturing Associate II

Company: Cepheid
Location: Newark
Posted on: November 17, 2021

Job Description:

With the support of Supervisors, Trainers, Quality Techs, and Engineering, a Manufacturing Associate II is essential to the manufacture of injection molded consumables for the use of Cepheid/Danaher Life Science Diagnostics finished goods. Associate II will be expected to provide guidance for Associate I while ensuring the successful completion and compliance in the initiation, maintenance, operation, packaging, inspection, environmental maintenance, and environmental control through injection molding. Manufacturing Associate II are the foundation to the Quality and Safety culture within the site and will be responsible to report as applicable, document when appropriate, and adhere to pertinent regulations and policies.ESSENTIAL JOB RESPONSIBILITIES:

  • Responsible for the production of injection molded consumables within the Lodi facility controlled environments
  • Adherence to applicable health and safety procedures and will be required to wear appropriate Personal Protective Equipment
  • Recognizes when minor issues and defects and utilizes the processes in place to resolve the occurrence
  • Applies reasonable logical and rational reasoning to control contingency, gaps, or nonconformance in the process
  • Completes necessary documentation and/or escalates accordingly
  • Collaborates with cross functional teams on special projects and troubleshoots problems
  • Reports production units, job numbers, and labor hours
  • Monitors machine problems and informs the Supervisors and Leads of any issues
  • Responsible for following documentation compliance
  • Operates Manufacturing Equipment for Basic Start and restart functions of the robot, press trouble shooting, conveyor feeding trouble shooting, and basic injection alarm resolution
  • Responsible for auxiliary production devices to support production including scanners, pads, and removable equipment
  • Maintains cleanroom standards, practices, work equipment and housekeeping according to Standard Operating Procedures
  • Coordinates and confirms rework for a tote, bin, or lot
  • Applies basic lean principals for First in and First Out (FIFO), Kaizen, 5S, and Standard Work
  • Adherence of regulations and procedures pertaining to the manufacture of medical devices including basic Quality Assurance, Good Manufacturing Practices, Standard Work Instructions, 21 CFR Part 820
  • Understands QMS requirements for traceability
  • Responsible for traceability during the production of the lot
  • Documents inspections, operations, rework, or tests performed consistently and in real time
  • Responsible for quality, accuracy, and timeliness of information, data, and communication within the Device History Record or Electronic Batch Record production log
  • Executes line clearance during cavity changes
  • Provides training to other associates as neededTRAINING RESPONSIBILITIES: (REQUIRED)
    • Complete all assigned and required training satisfactorily and on time
    • For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.MINIMUM REQUIREMENTS:Education or Experience (in years):
      • High school degree (or equivalent experience) with 1-2 years of relevant work experienceKnowledge and Skills:
        • Ability to comprehend verbal and written English to interpret documents such as safety rules, operating instruction, and procedure
        • Basic knowledge of Microsoft software (Word, PowerPoint, Excel, Outlook)
        • Ability to cooperate with co-workers in areas of safety, quality, production, maintenance, and engineering
        • Exhibits the ability to work calmly and accurately under varied conditions
        • Basic Knowledge of Quality Systems
        • Good Documentation Practices
        • Right First Time average greater than 99% effectivelyTechnical Knowledge and Skills:
          • Mechanical, Safety, Compliance, and Quality aptitude
          • Problem Solving, Quality Data, and Mathematics
          • General computation including addition, subtraction, multiplication, and division of all units of measure including whole numbers, common fractions, metric measurement, and decimals
          • Capable of using data to make determinations to resolve production related issues
          • Inspection and Inspection equipment
          • Ability to handle, interpret, and troubleshoot basic measuring devices such as a standard tape measurement, a micrometer, Caliper, pin gauges, drop gages, and height gages
          • Understands gage repeatability, gage resolution, and techniques for measurement
          • Recognizes and interprets measurements that are outside a specified range
          • Understands specifications, tolerance
          • Basic understanding of part drawings
          • Capability to understand the part control plan
          • Aptitude for interpreting the lot and tote acceptance criteriaPhysical requirements/abilities required:
            • Ability to work in a clean room environment
            • Ability to visually determine minute geometrical quality characteristics
            • Skilled hand-eye coordination for handling critical parts
            • Must have appropriate vision to perform detailed quality inspection as outlined in the SOPs, WIs, control plans, visual aids, and product drawings
            • Ability to stand at workstation for extended periods of time (8 hours or more) operating equipment and packaging products while closely monitoring and visually inspecting products and process
            • Ability to lift or carry 25 lbs. totes
            • Moves freely around machine to assure all working mechanisms are operating properly
            • Able to reach parts in machine and make adjustments, set-ups, change overs, inspections, feeding and securing partsPosture and Movement equal to but not less than requirement of the following:1-2 hours2-4 hours4-6 hours6-8 hoursStand Walk Sit Bend Reach Grasp Push/Pull Squat PREFERRED REQUIREMENTS:
              • Minimum two years in Manufacturing Environment
              • Experience working in a clean room environmentWhen you join us, you ll also be joining Danaher s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID 19 as a condition of employment, subject to reasonable accommodation as required by law.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.If you ve ever wondered what s within you, there s no better time to find out. Associated topics: assembly, brakes, fluid, mechanical engineer, mechanism, powertrain, solidworks, thermal, turbine, vehicle

Keywords: Cepheid, Newark , Manufacturing Associate II, Other , Newark, California

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