Quality Engineer II, Production Support

Menlo Park, CA 94025

Posted: 09/10/2018 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 13836

Quality Engineer II, Production Support

 

Responsible for supporting the quality needs of commercial and clinical operations.   Responsible for the establishment and maintenance of quality assurance standards, that adheres to QSR and ISO regulations.   Quality Assurance support for various Quality functions as assigned (e.g. Equipment Control and Calibration, NCMR, CAPA, Verification and Validation, Manufacturing process changes, Complaint Handling).

MAJOR DUTIES AND RESPONSIBILITIES: 
  • Support the commercial and clinical manufacturing activities on the production floor
  • Support quality Engineering support for incoming quality assurance including implementation of new inspection techniques, systems and troubleshooting.
  • Support product lot release activities
  • Perform NCMR investigations and related actions
  • Perform complaint investigation and RGA analysis
  • Develop/write protocols, coordinate the testing and write reports for validation activities, component qualification activities, IQ/OQs, gauge R&R studies
  • Work with Manufacturing Engineering and R&D on special projects, validation activities, developing inspection /test procedures, and process improvement activities as required.
  • Lead basic Quality Engineering projects
  • Perform CAPA investigation and implementation of corrective actions
  • Perform data analysis to support quality metrics
  • Revise Quality System procedures (SOPs and WIs)
  • Proactively identify and implement Quality System improvements
  • Support company goals and objectives, policies and procedures, QSR, and FDA regulations
  • Maintain accurate records/documentation related to quality, test results, and special projects
  • Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, Good Manufacturing Practices, and FDA regulations

EDUCATION /EXPERIENCE REQUIREMENTS:  
  • BS degree or equivalent experience
  • Minimum 2 years Quality Engineering or equivalent experience in medical device, pharmaceutical, or related industry.

OTHER QUALIFICATIONS:  
  • Strong written and verbal communication skills
  • Excellent organizational and time management skills required.
  • Experience with computer based applications (MS Word, MS Power Point, MS Excel)

Physical Activities:

Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.

Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.

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, and Working Conditions:

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.

The worker is subject to inside environmental conditions: Protection from weather conditions but not necessarily from temperature changes.

Jesse Ashworth

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