Senior Quality Assurance Engineer

Location: Pawtucket, RI, United States of America

Resuscitation

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!

Job Summary:

Responsible to support electrode product and process sustaining activities through the application of Quality engineering skills for medical devices. Focuses on process, equipment, design verification and validations, working with teams to develop manufacturing and quality processes and define their related tools, resolve validation strategy, and review and approve validations.

Essential Duties and Responsibilities:

  • Review and approval of verification and validation protocols and reports

  • Participate in Change Control review and approval activities as required

  • Provide technical guidance to QA and QC personnel

  • Participate in Risk Management process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971

  • Develop and implement Quality Plans

  • Ensures post market surveillance reviews are conducted and reports documented according to schedule

  • Participate in CAPA efforts, and apply systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues

  • Provide key quality trending information and data for Management Review and monthly KPI review, as applicable

  • Represent quality interests and concerns on project teams

  • Investigate causes of quality and yield problems identified in the field and throughout the manufacturing processes

  • Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements

  • Provide critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as process validation, equipment, test methods, root cause analysis, risk mitigation, process improvement tools, sampling plans, etc.

  • Provide quality and compliance support during regulatory audits and responses to government agency questions

  • Responsible for control of external standards

  • Provides Quality Assurance Leadership for Project Teams within the department

  • Participates in Design Review activities

  • Advise on interpretation of applicable standards and regulations

  • Participate in Material Review Board activities as required

  • Represents the Corporation and Quality Department in a professional manner

Required Qualifications:

  • Four Year degree, preferably in a technical discipline and minimum 5 years medical device experience

  • Proficient with Microsoft Office Suite

  • Familiarity with use of mechanical and electrical test equipment

  • Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing

  • Working knowledge of EN ISO 13485, ISO 14971 and FDA QSR for Medical Devices

Competences:

  • Ability to work in a fast paced, dynamic environment

  • High energy problem solver capable of driving items to closure

  • Excellent communication and interpersonal skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.

  • Ability to efficiently manage time, balance multiple task assignments and translate quality requirements into product specifications.

  • Understands basic applied statistics, statistical sampling plans, and statistical process control and sophisticated statistical methodologies.

  • Familiar with mechanical and electronic test equipment

  • Familiar with Minitab Statistical Analysis software (or equivalent)

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.  Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity.  Essential and marginal job functions are subject to modification.

 

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