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Principal quality engineer • usa
Principal Quality Engineer
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ZOLL MedicalSan Jose, CA, United States- serp_jobs.job_card.full_time
Principal Quality Engineer
At ZOLL, we're passionate about improving patient outcomes and helping save lives.
We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won't just have a job. You'll have a careerand a purpose.
Job Summary
As a Principal Quality Engineer, you will collaborate with the Quality Leadership team and other cross-functional individuals at all levels to ensure high levels of quality, safety, and effectiveness are maintained thorough all phases of product realization in compliance with the corporate quality system, the QSR and the applicable ISO Standards. You will provide support to product development for product assurance and reliability testing, risk analysis, verification and validation activities, and manufacturing support.
Essential Functions
- Ensure that the products are of high quality, safe, and effective at all stages of product realization process through the implementation and maintenance of an effective manufacturing quality assurance and quality control system
- Oversees product safety and reliability requirements. Participates in the assessment of product risk and works with engineers to implement and test risk mitigations
- Work with R&D on product development projects. Work with Manufacturing Engineering on product / process improvement projects. Works closely with software, mechanical, and electrical engineers to define system requirements
- Define verification / validation requirements for hardware and software and develop protocols in conjunction with appropriate functions, perform analyses, and document results in a report format consistent with process requirements
- Investigate and analyze failures. Recommend and implement corrective and preventive measures as necessary
- Provide training and assistance to inspectors
- Develop, implement and maintain inspection and test methods for finished products and incoming components and materials. Evaluate precision and accuracy of testing, measurement and production equipment.
- Interpret engineering drawings, schematic diagrams, or formulas and confer with engineering staff to determine quality and reliability standards.
- Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality expectancy of finished product. Recommend modifications of existing products, materials, or components to achieve the established quality standards and overall reliability standards
- Coordinate factory inspection by regulatory agencies certifying the products for electrical safety and EMC
- Perform inspection and testing of the products as assigned
Required / Preferred Education and Experience
Knowledge, Skills and Abilities
Physical Demands
The annual salary for this position is $180K to $195K. This position is eligible for an annual bonus in accordance with the company's bonus plans. Factors which may affect starting salary include geography, skills, education, experience and other qualifications of the successful candidate. Details on ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com .
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.