Akkodis · 1 day ago
Principal Quality Engineer
Marlborough, MA
Contract
Onsite
Lead/Staff
$65/hr - $67/hr
8+ years expAkkodis is seeking a Principal Quality Engineer for a 12-month contract with a client in Marlborough MA. This role ensures that IVD products meet stringent regulatory requirements and quality standards, leading quality engineering initiatives and driving continuous improvement in the quality management system.
Information Technology & Services
Hiring Manager
Tanisha Pratape
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 for 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)
ASQ Certification preferred
Regulatory Affairs Certification (RAC)
Benefits
Medical
Dental
Vision
Life insurance
Short-term disability
Additional voluntary benefits
An EAP program
Commuter benefits
A 401K plan
Paid Sick Leave
Holiday pay
Company
Akkodis
Akkodis provides digital engineering solutions for sustainable and innovative industries.
10001+ employees
H1B Sponsorship
Akkodis 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
2025 (141)
2024 (121)
2023 (67)
Funding
Current Stage
Late StageLeadership Team
Lane Greever
Chief Operating Officer (COO), Americas
Kishore Raj
Vice President & Partner: Technology and Engineering Consulting and Services
Recent News
2025-11-10
Canada NewsWire
2025-11-06
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