Pinnacle Technology · 2 hours ago
Principal Quality Engineer
Marlborough, MA
Contract
Hybrid
Lead/Staff
$65/hr - $69/hr
8+ years expPinnacle Technology is seeking a Principal Quality Engineer to ensure that Diagnostics’ IVD products meet stringent regulatory requirements and quality standards. This role involves leading quality engineering initiatives, supporting product development and manufacturing processes, and driving continuous improvement in the quality management system.
ConsultingInformation TechnologyOutsourcingSoftware
Hiring Manager
Himani Gupta
Responsibilities
Develop, implement and maintain quality systems and processes in compliance with FDA CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971 and other regulations, as appropriate, for IVD products
Conduct hazard analysis and risk assessments for IVD products according to ISO14971 throughout the IVD product lifecycle
Lead internal and external audits, including preparation, execution, and follow-up to ensure adherence to quality and client standards and regulatory requirements
Oversee corrective and preventive action (CAPA) processes, non-conformance investigations and deviations to resolve quality issues
Collaborate with cross-functional product development teams to integrate quality requirements into product design, verification and validation activities according to Design Controls
Review and approve design control documentation including design inputs, design outputs, verification/validation protocols and reports, and risk management documentation
Assess and qualify new suppliers in product development and throughout the product lifecycle
Establish and maintain Design History File for IVD products
Qualification
Required
8+ years of experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk management
Bachelor's Degree (Required)
Preferred
Experience in working effectively in an FDA-regulated environment
Experience working with IVD products
Analytical mindset with attention to detail and a commitment to integrity, product safety, and Quality
Demonstrated Experience applying medical device regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CAP, and 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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