Principal Quality Engineer

Location:
Marlborough, MA (Hybrid, required 3 or 4 days in office)

Duration: 12+ Months

Shift: 1st shift M-F 8-5 EST

• This role ensures that ***’ IVD products meet stringent regulatory requirements and quality standards.
• The Staff Quality Engineer will lead quality engineering initiatives, support product development and manufacturing processes, and drive continuous improvement in the quality management system.
• 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 ISO
  14971 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
  *** 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.

• 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.
• Education Bachelor’s Degree (Required)

• Experience 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).
• Knowledge:
  Experience with quality management system development, Design Controls, and risk management