Pride Global · 4 hours ago
Quality Engineer
Marlborough, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$60/hr - $65/hr
8+ years expPride Global is assisting a top diagnostic laboratory in Marlborough, MA, to find a Quality Engineer for a contract position. The role involves leading and maintaining quality systems compliant with regulatory standards and driving design control and risk management activities across the IVD product life cycle.
ConsultingHuman ResourcesInformation Technology
No H1B
Hiring Manager
Lindsey Gill
Responsibilities
Lead and maintain quality systems compliant with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IVDR
Drive design control and risk management activities across the IVD product life cycle
Review and approve design inputs/outputs, V&V documentation, and risk management files
Lead internal and external audits, CAPA, nonconformance investigations, and supplier qualification
Support regulatory submissions, complaints handling, and post-market surveillance activities
Collaborate cross-functionally to embed quality and regulatory requirements into product development
Analyze quality metrics and drive continuous improvement initiatives
Qualification
Required
Bachelor's degree required
8+ year experience in medical device/IVD
Strong design control and risk management expertise
Deep knowledge of FDA, ISO, and IVDR requirements
Must be authorized to work in the United States
Preferred
ASQ and/or RAC certification preferred
Benefits
Comprehensive healthcare coverage (medical, dental, and vision plans)
Supplemental coverage (accident insurance, critical illness insurance and hospital indemnity)
A 401(k)-retirement savings
Life & disability insurance
An employee assistance program
Identity theft protection
Legal support
Auto and home insurance
Pet insurance
Employee discounts with some preferred vendors
Company
Pride Global
Pride Global network of companies focuses on a diverse array of human resources solutions including managed services.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Anu Vettath
Chief Operating Officer
Recent News
2022-07-19
2022-03-09
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