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Manager, Production

Company: Truvian
Location: San Diego
Posted on: June 25, 2022

Job Description:

AboutTruvian is a healthcare company at the intersection of diagnostics and consumer tech. We are disrupting the blood testing industry by developing an automated, benchtop diagnostic system to provide lab-accurate results in 20 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample, in minutes, in a retail setting or private clinic.Truvian has also expanded our focus to address the surge in demand for antibody tests by introducing Easy Check COVID-19 IgM/IgG antibody test. This test will create higher standards of performance, speed, and scalability for the rapid detection of IgM/IgG antibodies to SARS-CoV-2.Job SummaryWe are looking for a talented Lean Manufacturing/Production Manager (depending on qualifications) to become a member of the Operations team at Truvian Sciences, reporting to the Director, Operations. Candidates with a proven track record of leading production teams in a GMP/ISO-13485 environment will be considered for the role. The scope of the work will include, but is not limited to, providing daily supervision of Production Operators, coordinating activities to meet the forecasted demand of consumables, training and developing production operators, compiling, and presenting production metrics, and helping to create/update manufacturing work instructions. As needed, the Production Supervisor/Manager may be required to perform consumables production alongside the Production Operators. This individual must be a strong communicator, as understanding and interpreting detailed instructions, along with the ability to relay those instructions to others both verbally and in writing, is a key element of this role. A background in GMP manufacturing and ISO-13485 environments is highly preferred.If you want to stand out, please include a cover letterResponsibilities

  • Ensures the production schedule is adhered to and supported in terms of staffing, work schedules, planning activities, and equipment maintenance.
  • Ensures cGMP guidelines, SOPs and Safety Guidelines are followed at all times.
  • Drive continuous improvement activities using lean mfg. principles & tools.
  • Writes new, amends current, and trains personnel on SOPs that accurately cover all activities within the department
  • Perform investigations for Deviation Reports accurately and thoroughly.
  • Prepare production documents, such as standard operating procedures, manufacturing batch records, inventory reports, or productivity reports
  • Manages production team on assembly and filling lines a manner that optimizes customer service and operation efficiency.
  • Tracks and reports production metrics and troubleshoots issues related to the execution of the production schedule.
  • Effectively able to communicate status of essential duties and responsibilities with different levels of the department.
  • Participates in company or department sponsored process improvement teams such as continuous improvement, variance reduction, training and development, and others.
  • Hires, trains, evaluates, promotes, and disciplines personnel.
  • Assists, as needed, to prepare and assemble materials, build product subassemblies or final assemblies
  • Present department status, improvement plans, and strategies to upper management
  • Other duties to be assignedQualifications And Skills
    • A minimum of 5 years of cGMP, ISO 13485 industry experience.
    • Must have minimum of 3 years as a Manufacturing Supervisor position in the medical device/biotech industry.
    • A minimum of 1 year of production manager experience.
    • 2+ years of Lean Manufacturing deployment experience.
    • Lean Certification and Six Sigma Certification (Green Belt, Black Belt) is preferred.
    • Technical writing skills, Project management skills.
    • Experience in a start-up and/or pilot production environment
    • Excellent written and verbal English communication skills
    • Mechanical aptitude with thorough knowledge of product assembly, fluid dispensing, and automated systems.
    • Intermediate level of Computer Skills - Excel, Word, PowerPoint, Visio.
    • Prior experience in medical device or IVD product development strongly preferred
    • Very strong analytical and problem-solving skills; organized and efficient
    • Proven interpersonal, communication, and presentation skills; excellent time management skills
    • Able to excel in collaborative, fast-paced, and evolving start up environment; able to manage competing priorities
    • Superb attention to detail; produces work of exceptional quality and accuracy.
    • Ability to proactively identify issues and address with solutions-oriented approach
    • Bachelor's degree, preferably in a technical field preferred.SUPERVISORY ROLE
      • YesPhysical Demands And Abilities
        • Regularly required to use hands to finger, handle or feel, reach with hands and arms and talk or hear
        • Ability to lift and move over 25 lbs. repeatedly and safely, occasionally 75 lbs. with assistance
        • Frequently required to stand, walk, stoop, kneel, crouch or crawl
        • Occasionally required to sit and climb or balance
        • Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus. What We Offer
          • Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K)
          • Flexible PTO
          • Kombucha on Tap
          • Variety of healthy snacks
          • Craft Coffee
          • Cold Brew on Tap
          • On Site Gym and Virtual Classes
          • On Site Restaurant - with a 30% discount Truvian provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Keywords: Truvian, San Diego , Manager, Production, Professions , San Diego, California

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