Quality Technician II, Swing Shift
1555 Adams Drive Menlo Park, CA 94025
PURPOSE OF JOB: Oversees and coordinates Quality Control activities for swing shift and for supporting the Quality needs of commercial production activities, receiving inspection, and other quality system support areas.
MAJOR DUTIES AND RESPONSIBILITIES:
- Coordinate daily swing shift QC inspection activities (Incoming Inspection, sterile load processing, lot release testing, commercial production support, etc) and priorities
- Perform inspections/ testing activities pertaining to IQA, in-process, final packaging inspection, product lot release, first article inspections (FAI), and product retain inspection.
- Perform Sterile Load processing and review.
- Support day to day manufacturing activities.
- Maintain the Receiving Inspection log.
- Train QC Technicians to inspection methodology and procedures.
- Send test samples (analytical test samples, dose audit test samples) out for testing
- Initiate NCMR and support associated investigations
- Conduct part history record review, data QC, and other actives as needed.
- Assist Quality Engineers in execution and completion of testing activities and gage studies as required
- Identify and implement process improvements for QC function.
- Thoroughly document all issues related to quality assurance, QSR, GMP and ISO compliance
- Support company goals and objectives, policies and procedures, QSR, and FDA regulations
EDUCATION /EXPERIENCE REQUIREMENTS:
High school diploma with a minimum of 3-5 years of experience in Quality inspection activities in the medical device industry.
- Strong written and verbal communication skills
- Strong communications and time management skills required.
- Excellent organizational and interpersonal skills
PHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS:
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).