Quality Control Inspector
Company: Bigfoot Biomedical Inc
Posted on: September 24, 2022
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.
- 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
- 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.
- Must be a self-starter and team player and able to work with
- Ability to work with minimal supervision.Education
- 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
- 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
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