Senior Quality Engineer

Location: San Jose, CA

Circulation

ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success. We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL! The Senior Quality Engineer will play a key role in the Quality function in support of Engineering and Production. This includes, but is not limited to, the development and continuous improvement of Quality Management System processes and documentation, providing design and development/sustaining support through Quality and Regulatory planning, management and execution of plans, complaint handling, root cause analysis, and quality auditing, both internal and external. 

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

EQUAL OPPORTUNITY EMPLOYER - DISABILITY AND VETERAN