ICONMA · 8 hours ago
Principal Quality Engineer- Pharma and Diagnostics
Marlborough, MA
Full-time
Hybrid
Lead/Staff
$67.13/hr - $69.71/hr
8+ years expICONMA is a Medical Research company seeking a Principal Quality Engineer specializing in Pharma and Diagnostics. The role involves developing and maintaining quality systems and processes in compliance with regulatory standards for IVD products, leading audits, and collaborating with product development teams to ensure quality requirements are met.
Staffing & Recruiting
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 Client 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
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
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 with quality management system development, Design Controls, and risk management
Communication (verbal and written), ability to build and manage an effective team, being able to influence others and drive for results, effective presentation skills, problem solving
Demonstrate ability to influence and create change
Strong interpersonal communication skills
Demonstrate strong writing and composition skills
Demonstrate success in motivating team members to reach objectives
Benefits
Health Benefits
Referral Program
Company
ICONMA
ICONMA: Your Partner in Global Staffing Solutions and Digital Transformation ICONMA is a globally recognized, Woman-Owned staff augmentation and technology consulting firm.
1001-5000 employees
H1B Sponsorship
ICONMA 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 (34)
2024 (31)
2023 (26)
2022 (39)
2021 (37)
2020 (69)
Funding
Current Stage
Late StageLeadership Team
Claudine George
Founder and CEO of ICONMA, LLC
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