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ZOLL Medical Corporation · 3 hours ago

Quality Assurance Engineer, 2nd Shift

Pawtucket, RI

Full-time

Onsite

Mid Level

$75K/yr - $95K/yr

3+ years exp

ZOLL Medical Corporation is dedicated to improving patient outcomes through innovative medical technologies. The Quality Assurance Engineer will support quality improvement initiatives, troubleshoot quality issues, and ensure compliance with regulatory standards while collaborating with manufacturing and R&D teams.

Health CareMedical DeviceSoftware

H1B Sponsor Likely

Responsibilities

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

Qualification

Quality ImprovementISO 13485FDA QSRStatistical AnalysisASQ Certified Quality EngineerProblem SolvingCommunication SkillsOrganizational Skills

Required

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

Understand and has applied in practice the concepts of process capability, process control, and measurement system capability

Preferred

ASQ Certified Quality Engineer desirable

Benefits

Annual bonus in accordance with the company's bonus plan

Comprehensive benefits plans

Company

ZOLL Medical Corporation

Glassdoor3.3

ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies.

Founded in 2004

Pittsburgh, Pennsylvania, USA

1001-5000 employees

https://www.lifevest.zoll.com

H1B Sponsorship

ZOLL Medical Corporation has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (13)

2024 (6)

2023 (8)

2022 (8)

2021 (2)

2020 (6)