Site Quality Assurance Engineer

THIS IS A SECOND SHIFT OPPORTUNITY.

Due to the on‑site requirements of this position, applicants are expected to reside within a reasonable commuting distance of the designated work location (Pawtucket, RI). This role does not offer relocation. 

ZOLL Medical does not provide immigration-related sponsorship for this role. Do not apply for this role if you will need ZOLL immigration sponsorship (e.g. H1B, TN, STEM, OPT, etc.) either now or in the future.

Job Summary

Responsible for supporting the Quality Assurance organization with quality improvement, supporting manufacturing, troubleshooting quality issues and monitoring quality trends; and interfacing with R&D to support new product introductions.  Primary responsibilities are to prepare and maintain necessary documentation, monitor production quality performance to identify opportunities for improvements, act as a liaison between manufacturing and quality to promote quality awareness. 

Essential Functions

Collaborate across functions, demonstrating quality and manufacturing expertise to solve problems, interpret data, and determine next steps.
•    Lead product complaint investigations, driving completion from receipt to resolution
•    Complete health risk assessments from product complaints or internal product/process/system issues
•    Develop and implement quality improvement programs
•    Support planning, review and approval of manufacturing process validations
•    Participate in change control activities for documents, manufacturing and QA/QC 
•    Provide technical guidance to QA and QC personnel
•    Represent quality interests and concerns on project teams
•    Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements
•    Collect, analyze and disseminate quality data throughout the organization
•    Participate in Material Review Board activities, including resolution of product nonconformities 
•    Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements
•    Participate in Risk Management activities
•    Monitor production quality performance to identify opportunities for improvements 
•    Engage and interface in internal and external audits providing subject matter expertise.
•    Participate in the CAPA program as a trained CAPA lead
•    Other duties as assigned

Required/Preferred Education and Experience

•     Requires a BS degree; science or engineering related discipline

•    3+ years related experience in a regulated environment, preferably medical device

•    Proficient at problem solving
•    Excellent verbal & written communication skills.
•    Familiar with Statistical Analysis
•    Experience with ISO 13485, ISO 14971 and FDA QSR for Medical Devices
•    Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines
•    ASQ Certified Quality Engineer desirable

Knowledge, Skills and Abilities

• Understands and has applied in practice the concepts of process capability, process control, and measurement system capability.

Physical Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

Working Conditions

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The noise level in the work environment is usually quiet.

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The annual salary for this position is:

This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at .

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.