Site Quality Assurance Engineer

ZOLL Medical Corporation•Pawtucket, RI

3d•$75,000 - $95,000•Onsite

About The Position

The Site Quality Assurance Engineer supports the Quality Assurance organization through quality improvement, manufacturing support, quality issue troubleshooting, trend monitoring, and coordination with Research and Development on new product introductions. The role prepares and maintains documentation, monitors production quality performance to identify improvement opportunities, and serves as a liaison between manufacturing and quality to promote quality awareness. The position collaborates across functions to resolve problems, interpret data, and determine next steps. It supports manufacturing, product development, and regulatory activities to ensure compliance with internal and external requirements, while maintaining adherence to Quality System procedures, work instructions, drawings, Good Manufacturing Practices, ISO standards, and FDA requirements. This is an onsite second-shift opportunity based in Pawtucket, Rhode Island. Applicants are expected to live within a reasonable commuting distance; relocation and immigration-related sponsorship are not offered. The position has an annual salary range of $75,000 to $95,000 and is eligible for an annual bonus under the company bonus plan.

Requirements

Bachelor of Science degree in a science- or engineering-related discipline.
At least 3 years of related experience in a regulated environment; medical device experience is preferred.
Problem-solving proficiency.
Excellent verbal and written communication skills.
Familiarity with statistical analysis.
Experience with ISO 13485, ISO 14971, and FDA Quality System Regulation (QSR) for medical devices.
Strong organizational skills and ability to manage and prioritize multiple tasks and meet deadlines.
Understanding and practical application of process capability, process control, and measurement system capability.

Nice To Haves

ASQ Certified Quality Engineer certification.
Experience in a regulated medical device environment.

Responsibilities

Collaborate across functions, applying quality and manufacturing expertise to solve problems, interpret data, and determine next steps.
Lead product complaint investigations from receipt through resolution.
Complete health risk assessments arising from product complaints or internal product, process, or 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 functions to ensure compliance with 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, GMP, ISO, and FDA requirements.
Participate in Risk Management activities.
Monitor production quality performance to identify opportunities for improvement.
Engage in internal and external audits, providing subject matter expertise.
Participate in the CAPA program as a trained CAPA lead.
Perform other duties as assigned.