MCRA, an IQVIA business · 22 hours ago
Senior Quality Engineer
East Providence, RI
Full-time
Onsite
Mid, Senior Level
4+ years expMCRA, an IQVIA business, is assisting a commercial-stage medical device company in recruiting a Senior Quality Engineer. The role is responsible for ensuring product quality and safety through various engineering and statistical techniques while managing multiple projects to meet quality objectives and regulatory requirements.
ConsultingHealth CareMedicalMedical Device
Hiring Manager
Miranda Gillis
Responsibilities
Investigate product complaints, manage returns, and perform root cause analysis
Track and report post-market data and update risk management files
Execute CAPA investigations and corrective actions
Maintain supplier quality through evaluations and audits
Ensure compliance with FDA, ISO 13485, MDD, and MDR standards
Support manufacturing changes, non-conformance reports, and device history reviews
Maintain sterilization validations and microbiological control programs
Serve as Quality representative on development teams
Ensure new products meet regulatory and quality standards
Develop inspection and quality plans; provide statistical guidance
Collaborate with Engineering on design reviews, verification/validation testing, and risk management (FMEAs)
Support process capability, equipment qualification, and validation activities
Support complaint processing, recalls, supplier quality, CAPA, audits, and management reviews
Assist with regulatory inspections and EU MDR transition
Qualification
Required
Natural Science degree
4–10 years in medical device quality or engineering (or 2 years with advanced degree)
Strong knowledge of validation, root cause analysis, CAPA, and ISO 14971
Adaptable, organized, and effective in fast-paced environments
Proficient in MS Office
Onsite
Preferred
Bachelor's in Engineering
Complaint investigation experience
SolidWorks
Company
MCRA, an IQVIA business
MCRA, an IQVIA business, is a leading full-service medical device, diagnostics, and biologics CRO and consulting advisory firm helping global healthcare companies maximize the value of their innovations.
51-200 employees
H1B Sponsorship
MCRA, an IQVIA business 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 (2)
2023 (1)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Michael Anselmo
Vice President of Reimbursement, Health Economics and Market Access
Recent News
2025-11-07
2025-07-22
Company data provided by crunchbase