Quality Control Inspector
Company: Bigfoot Biomedical Inc
Posted on: April 2, 2021
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! 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
- Prepare and organize the device history record for each
- Perform verification for all the labels by either visual or
- 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
- 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
- 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
- File the hardcopies of the completed LHRs and DHRs in the
designated documentation room. Experience Requirements
- Prefer 5 or more years of experience.
- Excellent written and verbal communication skills.
- Demonstrated experience with Microsoft Suite packages (Word,
- Must be a self-starter and team player and able to work with
- Ability to work with minimal supervision.
- Additionally, the ideal candidate will possess the
- Must be well organized and possess excellent organizational
skills and the ability to handle multiple areas of responsibility
- Must be flexible and adaptable in a fast-paced, start-up
- Team player/builder; must possess a "can-do" attitude.
- Ability and desire to be proactive not just reactive; a
- A creative thinker: one who looks for new and innovative ways
of doing things. Education Requirements
- High School diploma or equivalency is preferred. Physical
- 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
- Combined sitting, standing, and walking throughout the day to
- Occasional reaching, stretching, pushing, pulling, or
- Manual dexterity used frequently with repetitive finger
- 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
Keywords: Bigfoot Biomedical Inc, Milpitas , Quality Control Inspector, Other , Milpitas, California
Didn't find what you're looking for? Search again!