Site Quality Assurance Engineer

ZOLL Medical•Pawtucket, RI

2d•Onsite

About The Position

The Site Quality Assurance Engineer supports the Quality Assurance organization through quality improvement, manufacturing support, troubleshooting quality issues, monitoring quality trends, and interfacing with R&D 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. This is an on-site second-shift opportunity in Pawtucket, Rhode Island; applicants should live within reasonable commuting distance. Relocation and immigration sponsorship are not available. The position works across functions to resolve problems, interpret data, and determine next steps. It supports manufacturing, new product development, regulatory activities, and compliance with applicable internal and external requirements, including quality-system procedures, GMP, ISO standards, and FDA requirements. The role also contributes to complaint investigations, risk management, audits, CAPA, and product nonconformity resolution. The annual salary range is $75,000 to $95,000, and the position is eligible for an annual bonus under the company bonus plan. Starting salary may depend on geography, skills, education, experience, and other qualifications.

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 QSR for medical devices.
Strong organizational skills and the ability to manage and prioritize multiple tasks and meet deadlines.
Understanding and practical application of process capability, process control, and measurement system capability.
Ability to meet the physical demands of the role, including occasional lifting and/or moving of up to 25 pounds.

Nice To Haves

ASQ Certified Quality Engineer.

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 resulting 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 systems comply 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.
Follow 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.
Participate in internal and external audits, providing subject matter expertise.
Participate in the CAPA program as a trained CAPA lead.
Prepare and maintain necessary documentation.
Perform other duties as assigned.