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Quality Control Inspector

Company: Bigfoot Biomedical Inc
Location: Milpitas
Posted on: September 24, 2022

Job Description:

REGULATORY, QUALITY, & CLINICAL - QUALITY / Bigfoot believes people living with insulin-requiring diabetes deserve relief from its daily burden. We envision a world where the emotional, mental, physical, and financial burden of diabetes has been significantly reduced. We are passionately dedicated to delivering simpler, safer, and more effective solutions for life with insulin. We are personally committed to the mission of improving the lives of people with diabetes through the application of smart technology. We bring deep and nuanced understanding of customer needs, demonstrated technical capabilities in developing and commercializing technology, and proven business acumen in funding and growing startups into profitable publicly traded enterprises. What we are building at Bigfoot Biomedical Bigfoot is building diabetes management solutions integrating data, software, smart devices, and people. This is your chance to join a very talented team! Job Purpose: The Quality Control Inspector performs in-process and final inspection on sub-assembly and final products. This position also performs LHR reviews to ensure that all the manufacturing lot/batch records are complete and accurate. This position is expected to perform other Quality related tasks as instructed by the departmental manager. Essential Duties and Responsibilities: Inline Inspection --- Perform inspection for sub-assembly and final assembly. --- Issue a build request number for special build (SBR) as required. --- Prepare and organize the device history record for each build. --- Perform verification for all the labels by either visual or scanning method. --- Review the daily line clearance to verify that all the equipment, tools and fixtures used on the manufacturing floor are within the calibrated and/or preventative maintenance and maintaining applicable equipment file updates. --- Verify the revisions of the kitted components are the current revisions, and that the kitted materials are within expiration dates if applicable. --- Review manufacturing test records to verify that the test results are complete and pass. --- Assist with inline data collection for tracking and trending purposes. --- Generate NCR and assist QE to process the NCR as needed. Final Inspection --- Review final test records to verify that the test results are complete and pass. --- Perform visual inspection on final assemblies against the final acceptance criteria. Finished Goods Packaging Inspection --- Perform label verification of finished goods packaging against current released specifications and procedures. --- Perform box audit of the finished goods packaging and its contents to ensure that the contents are correct and matching with the sale order. LHR reviews --- Perform lot history record review for the sub-assemblies, final assembled devices, and finished goods packaging. - --- Verify that any components with down revisions in the LHR has a justification. Contact the QE to verify that the justification is appropriate. The QE at his/her own discretion can decide to attach documentation to supports the justification as needed. --- Release products to the designated location --- Assemble the device history records and associate supporting documentation such as battery test records, NCR records, deviation and/or equipment IQ records. --- Forward the complete DHR to QE for review and closure. LHR / DHR Filing --- Scan all the completed LHRs and their associate test records into a designated Quality location. --- Scan all the completed DHRs into a designated Quality location. --- File the hardcopies of the completed LHRs and DHRs in the designated documentation room. Experience Requirements:

  • 5 or more years of experience in quality inspection in a regulated industry (FDA).
  • Excellent written and verbal communication skills.
  • Demonstrated experience with Microsoft Suite packages (Word, Excel, PowerPoint) Additionally, the ideal candidate will possess the following:
    • Must be well organized and possess excellent organizational skills and the ability to handle multiple areas of responsibility concurrently. -
    • Must be flexible and adaptable in a fast-paced, start-up environment.
    • Team player/builder; must possess a "can-do" attitude.
    • Ability and desire to be proactive not just reactive; a questioning mindset.
    • A creative thinker: one who looks for new and innovative ways of doing things.
    • Must be a self-starter and team player and able to work with minimal supervision.
    • Ability to work with minimal supervision.Education Requirements:
      • High School diploma or equivalent.Physical Demands:
        • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
        • Combined sitting, standing, and walking throughout the day to accomplish tasks.
        • Occasional reaching, stretching, pushing, pulling, or crouching.
        • Manual dexterity used frequently with repetitive finger motion.
        • Be able to lift up to 40 pounds occasionally.
        • Hearing and speaking required regularly.
        • Specific vision abilities include close and distance vision, depth perception, peripheral vision, and ability to adjust focus. What will you do at Bigfoot Biomedical? What you do here at Bigfoot will largely be defined by your existing skills and desire to grow to help us achieve the above. We have an employee-friendly working environment that provides bike racks and showers, lunch and snacks, and flexible hours. Our culture helps us stay focused on our goals. We have competitive benefits. We have a great team culture. We understand that we all need to succeed as a team. We have fun while we're building a solution we can be proud of. If you're ready to make a dent in the universe, join the mission, and feel like what you do every day isn't just a job, come talk to us! Bigfoot Biomedical, Inc., provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

Keywords: Bigfoot Biomedical Inc, Milpitas , Quality Control Inspector, Other , Milpitas, California

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