Sr. Technician, Quality Control
1555 Adams Drive Menlo Park, CA 94025
Menlo Park, CA
Shift 1 is 6am-2: 30pm.
PURPOSE OF JOB: Support quality assurance and adhere to QSR and ISO regulations.
MAJOR DUTIES AND RESPONSIBILITIES:
· Perform inspections/ testing activities pertaining to IQC, in-process, final packaging inspection, product lot release, verification /validation testing activities, first article inspections (FAI), and product retain inspection.
· Support day to day manufacturing activities.
· Generate detailed and accurate inspection and testing reports according to Current Good Manufacturing Practices (cGMP) and maintain inspection and testing files.
· Generate and assist in NCMR investigations as assigned.
· Maintain IQC records, QC related logs and databases (e.g. IQC, NCMR).
· Perform QA related data entry and generate reports as required.
· Perform Sterile Load processing and review.
· Process RGA product, as appropriate.
· Assist Quality Engineers, Manufacturing Engineers and R&D Engineers in developing inspection/test procedures, test method validations, and gage studies as assigned.
- Coordinate test requests and shipments to contract laboratories.
· Implement improvements to inspection and test documentation, and Quality System procedures.
· Assist in identifying continuous improvement opportunities.
- Support company goals and objectives, policies and procedures, QSR, and FDA regulations
- Audit production lines to ensure QSR/GMP compliance as assigned.
· Perform Device History Records review and product release activities as assigned.
- Perform other QA related activities as assigned.
- Train new Quality Control Technicians
EDUCATION /EXPERIENCE REQUIREMENTS:
- Associate degree or equivalent industry experience preferred.
- Certified Quality Technician (CQT) or Certified Quality Improvement Associate (CQIA) preferred.
- Minimum of 5 years of experience performing QA inspections/testing activities pertaining to IQA, in-process, lot release and V&V, and administration of various Quality Systems in the medical device industry.
· The ability to understand and follow Quality System Procedures (e.g. SOP and Test Methods).
· Strong understanding of, cGMP, QSR and ISO13485: 2003 requirements.
· Working knowledge in reading and interpreting technical specifications and mechanical drawings.
· Strong knowledge of a wide variety of inspection and test equipment, and methodologies.
· Experience with computer-based applications (MS Word, MS Access, MS Excel, ERP)
· Excellent written and verbal communication skills.
· Strong time management skills and the ability to multi-task in a fast-paced environment.
· Excellent organizational 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. Standing: Remaining upright on the feet, particularly for sustained periods of time.
- 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).