Pinnacle Technology · 3 hours ago
Principal Quality Engineer
Marlborough, MA
Full-time
Onsite
Lead/Staff
$60/hr - $70/hr
8+ years expPinnacle Technology is seeking a Principal Quality Engineer who ensures that in-vitro diagnostic (IVD) products meet all quality and regulatory requirements. This role leads quality activities across product development, manufacturing, and post-market processes while driving continuous improvement in the quality management system.
ConsultingInformation TechnologyOutsourcingSoftware
Hiring Manager
Kuldeep Singh
Responsibilities
Ensure compliance with FDA, ISO, IVDR, and other medical device regulations
Lead design control and risk management activities throughout the product lifecycle
Conduct risk assessments and hazard analyses for IVD products
Lead and support internal and external audits
Manage CAPA, deviations, non-conformances, and quality investigations
Review and approve design and validation documentation
Support supplier qualification and quality oversight
Maintain Design History Files (DHF)
Track and analyze quality metrics and trends
Support regulatory submissions and product approvals
Manage complaints, post-market surveillance, and incident reporting
Drive continuous improvement and update quality procedures and training
Collaborate with cross-functional teams
Qualification
Required
Bachelor's degree
8+ years of experience in Medical Devices or IVD
Strong experience in design control and risk management
Experience working in FDA-regulated environments
Knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, IVDR
Preferred
ASQ Certification
Regulatory Affairs Certification (RAC)
Experience with regulatory standards such as IEC 62304, CAPA, CLIA
Company
Pinnacle Technology
Pinnacle Technology provides staffing solutions, outsourcing, and systems integration services.
201-500 employees
Funding
Current Stage
Growth StageRecent News
GlobeNewswire News Room
2025-02-21
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