Site Quality Assurance Engineer

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

• Prepare and maintain necessary documentation
• Maintain 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
• 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
• 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

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

Physical Demands

• Sit and talk or hear
• Occasionally stand; walk and reach with hands and arms
• Occasionally lift and/or move up to 25 pounds

Working Conditions

• The noise level in the work environment is usually quiet

Annual Salary

$75,000.00 to $95,000.00

Details of ZOLL's Comprehensive Benefits Plans

Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Application Process

Applications will be accepted on an ongoing basis until this position is filled.

Remote Work Considerations

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.