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Quality Technician - Temporary (ONSITE)

Company: RefleXion Medical
Location: Hayward
Posted on: January 21, 2023

Job Description:

Who We Are RefleXion is developing the SCINTIX biology-guided radiotherapy machine that is the first to utilize the cancer's biology itself to control radiation delivery, even in tumors that are moving. By using positron emission tomography (PET), RefleXion's platform enables a leap forward in the ongoing goal of conventional radiotherapy to manage motion, and potentially diminish radiation toxicity, making it feasible to one day provide more options for patients with advanced stage cancer. Currently, the RefleXion X1 machine is cleared by the U.S. Food and Drug Administration (FDA) for the delivery of stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT). Find out more about RefleXion and SCINTIX therapy at . Stay up to date with RefleXion by following our channels here: LinkedIn , Twitter , Facebook , Instagram , YouTube . SCINTIX biology-guided radiotherapy is pending regulatory review and is not commercially available. About This Role The Quality Technician will perform a variety of inspection and quality tasks in support of manufacturing operations and new product development activities. Perform daily activities in the IQC lab including completion of inspections while meeting priorities. Assure compliance with the RefleXion Medical Quality Management System (QMS). What You Will Be Doing

  • Provide work direction and guidance of issues relating to quality of products and schedule attainment.
  • Complete inspection of incoming materials including machined components, sheet metal parts, mechanical assemblies, printed circuit board assemblies, fasteners, and adhesives, per engineering drawings, specifications, and Quality Inspection Plans (QIP).
  • Lead and implement best measurement techniques for incoming inspection.
  • Review supplier provided documentation including certificates of conformance, material certifications, and special process certifications.
  • Complete material acceptance and rejection transactions in ERP system.
  • Coordinate MRB activities and initiate NCR's as required to ensure the proper disposition of non-conforming materials as required in the QMS.
  • Complete and review First Article Inspections (FAI) as required.
  • Create or assist in generating Quality Inspection Plan (QIP)
  • Monitor performance of quality control systems to ensure effectiveness and efficiency.
  • Perform manufacturing in-process and final inspections per inspection plans as required.
  • Assist in calibration and preventive maintenance activities with outside suppliers.
  • Perform and/or participate in quality system audits as assigned, report findings, and make suggestions for improvement.
  • Support new product development activities as needed.
  • Perform all other duties as assigned.
  • Other duties as assigned Where You Will Do This Job
    • Hybrid - This position will allow the successful candidate to work on a Hybrid work location schedule. They must be based in the greater SF Bay Area and must be able to commute into the RefleXion office in Hayward 1-4 days a week, depending on the role. What We Need
      • Minimum of 10 years of inspection experience, preferably in the medical device industry.
      • Understanding of 21 CFR 820 Regulations and ISO 13485 Standards.
      • Ability to read and interpret engineering drawings required.
      • Solid proficiency in GD&T required.
      • Working knowledge in the use of standard metrology tools including surface plates, calipers, micrometers, height gages, bore gages, indicators, pin gages, and gage blocks.
      • Experience programing and operating coordinate measuring machines (CMM)
      • Familiar with vision systems and optical comparators.
      • Working knowledge of gage R&R, test method validation & equipment qualification.
      • Understanding of statistical process control (SPC).
      • Excellent verbal and written communication skills with attention to detail.
      • Must be motivated and work with minimal supervision in a start-up fast-paced environment.
      • Computer skills including Microsoft Office (Word & Excel), email, and other common programs.
      • Ability to lift up to 50 pounds. What You Will Love About Working with Us!
        • The opportunity to work with a passionate, driven team in a pre-IPO start-up environment
        • Flexible work location and schedule - hybrid work environment for many positions
        • Competitive compensation and Pre-IPO stock option packages
        • Medical (both HMO and PPO options), Dental and Vision
        • Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
        • Pre-tax Commuter Benefits
        • Employee Assistance Program (EAP)
        • 401(k)
        • 3 Weeks/Year PTO Accrual rate to start and 12 Paid Company Holidays
        • Employer paid Life Insurance, short-term and long-term disability
        • RefleXion Benefit Hub -Company exclusive discounts and deals on a variety of sites and items
        • Weekly catered on-site lunches as well as kitchens filled with a variety of healthy and delicious food and drinks - including an espresso machine and panini stations!
        • Employee Events - Variety of Workshops, Lunch 'n Learns, Financial Wellness education, Regular "Coffee Chats" with Executive Leadership, Scavenger Hunts, Company Milestone celebrations and more!
        • Electric car charging stations on site The pay range for this role is $24.00 - $48.00. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Values and Diversity RefleXion is an equal opportunity employer. All aspects of employment including the decision to hire will be based on merit, competence, performance, and business needs. We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, disability/medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Keywords: RefleXion Medical, Hayward , Quality Technician - Temporary (ONSITE), Professions , Hayward, California

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