Senior Quality Engineer

Peninsula, CA

Posted: 12/07/2018 Employment Type: Direct Hire Industry: Medical Device Job Number: JOS000008297

PURPOSE OF JOB: Responsible for supporting the Quality Engineering needs of commercial, R&D and clinical operations. Responsible for the establishment and maintenance of quality assurance standards, that adheres to cGMP, QSR and ISO regulations. Quality Assurance oversight of various Quality functions as assigned (e.g. NCMR, CAPA, Manufacturing Process changes, Verification and Validation).

 

MAJOR DUTIES AND RESPONSIBILITIES:

  • Support the daily commercial manufacturing activities and work with Manufacturing Engineers to resolve line issues and implement corrective actions.

  • Provide technical support for incoming inspection activities and lot release testing activities

  • Identify and assist with implementation of corrective and preventative actions related to production or Quality System improvements 

  • Lead investigation and drive closure of non-conforming material (NCMRs) in a timely manner.

  • Work with Supply Chain to resolve supplier quality issues

  • Lead the investigation and closure of RGA product and product complaints

  • Develop and revise Quality System procedures (SOPs and WIs).

  • Create and maintain Quality Plans for Quality Engineering activities and special projects

  • Develop test methods and lead test method validation activities.

  • Develop/write protocols and coordinate the testing for validation activities, component qualification activities, IQ/OQs, gauge R&R studies as necessary

  • Lead Quality engineering projects as assigned including developing project plans and facilitating the completion of all necessary activities

  • Responsible for maintaining risk management files for commercial products

  • Facilitates problem solving, root cause analysis, and other continuous improvement initiatives.

  • Support product sterilization validation activities and cleanroom environmental monitoring activities

  • Provide training and/or technical guidance to QA Technicians and production staff as required.

  • Provide statistical data analysis and interpretation support for investigations, specification setting activities, and test protocols

  • Participate in inspections for FDA, FDB, ISO, MDD, and other regulatory agencies

  • 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: Bachelor's degree in Engineering/Life Sciences and a minimum of 5 years’ medical device experience. Experience with quality system elements pertaining to combination products (drug/device) and QSR, cGMP and ISO 13485 familiarity is strongly preferred.  

 

OTHER QUALIFICATIONS: Strong written and verbal communication skills and attention to detail. Must work independently and have the ability to mentor junior quality associates. Self-Starting, detail oriented, quick learner, creative and analytical. Capable of understanding and analyzing complex engineering problems. 15% travel may be required.

 

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).

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