In-Process Quality Inspector II
Sheathing Technologies, Inc., founded in 1992, is a medical device manufacturer of Ultrasound Probe Covers, FDA-Cleared Viral Barriers, Adhesives, Needle Guides Kits, Ultrasound Gel, and Storage/Transport Covers. We are the global leader of infectious control solutions. More than 99% of our products are manufactured in the United States with the bulk of it right in our facility located in Morgan Hill, CA. As market leaders, our technological advancements for ultrasound procedures have enabled us to continually increase quality, year after year. We are looking to expand our team and are now accepting applications for an In-Process Quality Inspector II.
Our biggest accomplishment in recent history has been to develop and create the world's only FDA cleared Viral Barrier – providing infectious control and save people's lives. This product provides our clinicians and their patients with a complete barrier to all bacteria and all currently known testable viruses.
Sheathing Technologies, Inc. is committed to providing a comprehensive benefits package to all of the company's employees. We offer standard benefits such as medical, dental and optional vision coverage, life insurance, 401(k) matching plan & tuition reimbursement. The benefits offered by Sheathing Technologies, Inc. is designed to positively impact all aspects of your life; to help you and your family succeed and to maintain our status as a “perfect job”. Come find out what Sheathing Technologies, Inc. has to offer you.
As an In-Process Quality Inspector II in our Morgan Hill, CA facility your essential duties & responsibilities will be:
Inspection Activities
- Perform accurate physical and visual inspections of raw materials, components and assemblies, and final product as per Inspection plans or specification requirements.
- Determine whether the product conforms to product specifications.
- Initiate non-conformance reports as required.
- Detecting, correcting, and preventing waste or loss of raw material or partially finished product.
- Perform verification for all the labels by either visual or scanning methods.
- Review the daily line clearance to verify that all the equipment, tools, and fixtures used on the manufacturing floor are within the calibrated due dates.
- Verify the revisions of the kitted components are the current revisions, and that the kitted materials are within expiration dates if applicable.
Manufacturing History Record Review Activities
- Perform lot history record review for the sub-assemblies, final assembled devices, and finished goods packaging
- Review final test records to verify that the test results are complete and pass.
- Review manufacturing test records to verify that the test results are complete and pass.
- Provide training and/or guidance to other Quality In-process Inspection personnel.
- Contributes to the development of quality systems working instructions.
- Reads and interprets sampling plans to determine sample size and/or accept/reject criteria
- Release products to the designated location
Additional Requirements
- Assist with data collection for tracking and trending purposes.
- Complies with documentation and FDA procedures and policies
- Identify and implement opportunities for continuous improvement – under supervision
- Strong attention to detail and ability to identify minute defects
- Proficiency in using measuring tools and testing equipment
- Knowledge of quality control methodologies and standards
- Good analytical and problem-solving skills
- Ability to work independently and as part of a team
- Excellent documentation and reporting skills
- Basic understanding of manufacturing processes
- Associate degree and 1-3 years of experience in quality inspection or manufacturing or
- High school diploma or GED and 4 - 6 years of experience in quality inspection or manufacturing.
- Demonstrated ability to develop, communicate, and influence solutions to complex problems.
- Demonstrated experience with Microsoft Suite packages (Word, Excel)
- Must be able to complete detailed documentation accurately.
- Exercises judgment within well-defined and established procedures and practices to determine appropriate actions.
- Shows strong initiative and independence. Able to perform routine work and fulfill responsibilities with little or no additional instruction.
- Detail-oriented with good organization and time management skills.
- Strong interpersonal and verbal/written communication skill required.
- Ability to effectively participate and contribute on multi-disciplinary teams.
Salary: $27.50 - $35 per hour