Quality Engineer II- Pilot Plant

  • Company: Johnson & Johnson
  • Posted: February 17, 2017
  • Reference ID: 5949170206-en-us

Under general supervision, participate in New Product Development teams to develop products, design verification tests, process validations and quality processes to ensure compliance with company Quality System policies, procedures, standards (FDA, ISO 13485, CMDCAS, PMDA) and other worldwide regulatory agencies that pertain to medical devices. Support production floor activities (IQ/OQ/PQ) and product quality investigations. Work is well defined and is checked for progress and reviewed for accuracy upon completion.


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The listed requirements are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Primary responsibilities include assisting in a supporting role on new product development projects. Assist in the development of effective quality control and associated risk management plans.
  • Write process and product validation protocols and reports, equipment qualifications, engineering change orders.
  • Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
  • Assist in Failure Mode and Effects Analysis activities for both Design and Process FMEA's.
  • Help to ensure that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MOD, and product is properly transferred to manufacturing.
  • Assist in planning necessary to ensure effective product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans.
  • Participate in MRB review of nonconforming product; recommend disposition and corrective action.
  • Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
  • Assist in complaint analysis as appropriate.
  • Moderate exercise of judgment is required on details of work and in making selections and adaptations of engineering alternatives.
  • Receives general direction on new aspects of assignments.
  • Performs work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features for which there are precedents.
  • Specifies inspection and testing methodologies, mechanisms, and equipment.
Property of Biosense Webster                          Proprietary and Confidential                                                     Page  1  of  3

    • Recommends revision of specifications to the NPD team.
    • Responsible for communicating business related issues or opportunities to next management level.
    • Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
    • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
    • Performs other duties assigned as needed.



  • Bachelor's degree or equivalent in engineering and/or scientific discipline
  • A minimum of 2 years work experience required.
  • Master’s degree preferred.
  • American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
  • Ability to develop and implement Quality standards.
  • Knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices.
  • Knowledge of Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.
  • Ability to apply project management skills to fulfill new product development requirements.
  • Auditing and problem solving skills.
  • Exposure to Six Sigma and Process Excellence tools and methodologies. Lean manufacturing experience desirable.
  • Some understanding of business and financial metrics.
  • Have a basic understanding of theoretical and practical fundamentals and experimental engineering techniques.

    • Estimate travel 5 - 10%, domestic and international.
    • Competent using MS Office (Word, Excel, PowerPoint, Outlook, etc).
    • Ability to multi-task and manage multiple assignments in a timely manner.
    • Good verbal and written communication skills.
    • Strong interpersonal skills.

Primary Location
United States-California-Irwindale
Biosense Webster Inc. (6010)
Job Function
Quality (Eng)

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