Senior Quality Engineer

Location: San Jose, CA

Circulation

Responsibilities include:

  • Contribute as a core team member of product development teams, representing the Quality Assurance function in activities such as Design FMEAs and risk analysis. • Develop quality inspection procedures, including sampling plans, for production components and finished devices. Supports Incoming Quality Control inspection in the performance of quality inspection and testing, including development of inspection fixtures.
  • Support the supplier selection and qualification process with supplier audits, as well as Supplier Corrective Action Reports.
  • Contribute to process validation, design verification, and design validation. Provide input regarding appropriate statistical methods, test methodologies, test facilities, and test equipment.
  • Develop and maintain Quality Plans throughout the product life cycle beginning with project inception/initiation.
  • Investigate nonconforming materials and provide input to Material Review Board activities.
  • Coordinate sterilization validation, packaging validation, and biocompatibility testing.
  • Assist in the complaint and failure investigation process, as needed.
  • Conduct internal audits, as assigned.
  • Maintain and comply with ZOLL SOP’s. Review procedures to ensure adequacy for device development to conform to business and Quality Management System requirements.

Education Requirements:

  • Requires a B.S. degree in engineering or related field 
  • Minimum 2+ years experience in a medical device design, manufacturing, or quality engineering environment. Preferable experience includes capital equipment and disposable (catheter) development and manufacturing.
  • Experience using Microsoft Word, Excel.

Skills:

  • Demonstrated technical skills in the development and manufacturing of medical devices.
  • Good communication skills, both written and oral, and must be computer literate.
  • Knowledge of and experience in developing and manufacturing medical devices in conformance with FDA Quality System Regulation and ISO 13485:2003 requirements.
  • Knowledge of analytical tools and methods related to design, development, and manufacturing, including statistics, DOE, and the use of computer/software packages.
  • Understanding of continuous improvement methodologies including Lean and Six Sigma.
  • Must possess a high sense of urgency, initiative and common sense.
  • Must present a professional demeanor and demonstrate an ability to work effectively with a diverse group of individuals.
  • Must be energetic, work quickly and efficiently with detail and accuracy.

 

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V. 

ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990

 

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