Pride Health · 7 hours ago
Principal Quality Engineer
Marlborough, MA
Contract
Hybrid
Lead/Staff
$60/hr - $70/hr
8+ years expPride Health is hiring for a Principal Quality Engineer to support their client’s medical facility based in Marlborough, MA. This role ensures that IVD products meet regulatory requirements and quality standards, leading quality engineering initiatives and supporting product development and manufacturing processes.
HealthcareHuman ResourcesInformation TechnologyHealth Care
Hiring Manager
PRAVEEN KUMAR
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
Establish, monitor and analyze quality metrics, trends and performance data to identify areas of improvement
Support regulatory submissions and activities for IVD product approvals
Support complaints process (review, process, investigate, trend quality data, etc.) and post-market incident activities
Support post-market incident activities
Manage post-market incident activities (field action, MDRs, EU incident decision/reporting, field failure trending)
Maintain knowledge of laboratory regulatory requirements, including accrediting bodies, federal, state, and local requirements as well as Quest Diagnostics policies
Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance data
Stay current with evolving regulatory requirements, standards, and industry trends
Proactively update internal processes, policies and procedures, and training materials as needed
Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance data
Stay current with evolving regulatory requirements, standards, and industry trends
Proactively update internal processes, policies and procedures, and training materials as needed
Follow corporate policies and procedures
Perform other duties as assigned
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)
Experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk management
Benefits
Comprehensive healthcare coverage (medical, dental, and vision plans)
Supplemental coverage (accident insurance, critical illness insurance, and hospital indemnity)
401(k)-retirement savings
Life & disability insurance
An employee assistance program
Legal support
Auto, home insurance
Pet insurance
Employee discounts with preferred vendors
Company
Pride Health
Pride Health is a staffing and recruiting company that provides account management and staffing solutions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Stephanie Barnes
Scheduling Lead PHC/OPWDD
Recent News
2025-11-06
Company data provided by crunchbase