Dynamic innovative medical device company in Fremont, CA seeks Senior Quality Inspector. Enter
Job Number M12127 on subject line of response email when applying to HR@Alara.com
GENERAL DESCRIPTION: Performs inspection of incoming materials used in the manufacture of
medical devices and final inspection of those devices. Coordinates calibration and provides
support to other quality system activities.
MAJOR DUTIES AND RESPONSIBILITIES: Responsibilities include the following. Other duties may
Performs inspections of purchased parts according to sampling procedures and well-defined
criteria using standard physical, mechanical, and/or electrical measurements.
Verification of inspection or test data provided with incoming materials.
Conduct and document method audits using written procedures as audit standards.
Perform calibration coordination duties
Perform in-house verification of calibrated tools in accordance with defined criteria
Accurately document the results of inspections, verifications, and testing.
Maintain all controlled document files and test records in a timely and accurate manner.
Performs final QC of cosmetics and paperwork for final products.
Participate in the construction and/or revision of SOPs for the inspection function. Assist
in writing and updating inspection procedures, protocols, and checklists.
Evaluate problems and make initial recommendations for possible corrective action to
EDUCATION/EXPERIENCE REQUIREMENTS: High School graduate equivalent required. ASQ qualified
as a Mechanical Inspector or Quality Technician. AA in a technical field preferred. Five
years inspection experience. Familiar with use of MRP systems. Knowledgeable in the use and
limitations of typical inspection tools and able to read mechanical and electrical drawings.
Must be able to work on assignments that are moderately complex in nature where judgment is
required in resolving routine problems and making routine recommendation. Must be able to
OTHER QUALIFICATIONS: Good math and verbal/written communication skills. Computer literacy
is required. Familiar with FDA and/or typical international quality system requirements. Due
to manufacturing and reliance on this key individual, dependability and the ability to work
consistent hours are crucial.
PHYSICAL DEMANDS: The physical demands described below 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
While performing the duties of this job, the employee is frequently required to stand; walk;
sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; talk;
and hear. The employee must occasionally lift and/or move up to 45 pounds. Specific vision
abilities required by this job include close vision and color vision.
Enter Job Number M12127 on subject line of email when responding to HR@Alara.com