ZOLL Cardiac Management Solutions ยท 4 months ago
Quality Assurance Engineer, 2nd Shift
Pawtucket, RI
Full-time
Onsite
Mid Level
3+ years expZOLL Cardiac Management Solutions is dedicated to improving patient outcomes through innovative technologies in the medical field. The Quality Assurance Engineer will support the QA organization with quality improvement, troubleshoot quality issues, and interface with R&D to support new product introductions.
Medical Device
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
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
Preferred
ASQ Certified Quality Engineer desirable
Company
ZOLL Cardiac Management Solutions
ZOLL Cardiac Management Solutions (CMS), a division of ZOLL Medical Corporation, offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes in cardiac patient care.
1001-5000 employees
H1B Sponsorship
ZOLL Cardiac Management Solutions 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
2024 (1)
2022 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageCompany data provided by crunchbase