Principal Quality Engineer in Marlborough

The Principal Quality Engineer is responsible for developing, implementing, and maintaining quality systems and processes for In Vitro Diagnostics (IVD) products in compliance with applicable regulatory and quality standards. This role partners closely with cross-functional teams to ensure quality is embedded throughout the product lifecycle, from design and development through post-market activities.

Responsibilities

• Develop, implement, and maintain quality systems in compliance with FDA 21 CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971, and other applicable regulations.
• Conduct hazard analysis and risk assessments throughout the IVD product lifecycle in accordance with ISO 14971.
• Lead internal and external audits, including preparation, execution, follow-up, and corrective actions.
• Oversee CAPA processes, non-conformance investigations, and deviations to resolve quality issues.
• Collaborate with cross-functional product development teams to integrate quality requirements into design controls, verification, and validation activities.
• Review and approve design control documentation, including design inputs, outputs, verification and validation protocols, reports, and risk management files.
• Establish and maintain Design History Files (DHF) for IVD products.
• Assess, qualify, and monitor suppliers during development and throughout the product lifecycle.
• Establish, monitor, and analyze quality metrics and performance trends to drive continuous improvement.
• Support regulatory submissions and product approval activities.
• Support and manage complaint handling and post-market incident activities, including investigations, trending, field actions, and regulatory reporting.
• Maintain knowledge of laboratory regulatory requirements and applicable accrediting body standards.
• Drive continuous improvement initiatives using audit findings, post-market surveillance data, and industry best practices.
• Stay current with evolving regulatory requirements and industry standards.
• Update internal processes, procedures, and training materials as needed.
• Follow corporate policies and procedures and perform other duties as assigned.

Experience

• 8+ years of experience in medical device and/or IVD design and development with strong focus on design controls and risk management.
• Experience working in FDA-regulated environments preferred.
• Experience supporting IVD products preferred.

Skills

• Strong verbal and written communication skills.
• Ability to influence others and drive results.
• Effective presentation and problem-solving skills.
• Strong analytical skills with high attention to detail.
• Team leadership and cross-functional collaboration skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to function effectively in a matrix organization.
• Strong organizational and project management skills.

Knowledge

• Quality Management Systems development.
• Design Controls and Risk Management.
• Medical device and IVD regulations including IEC 62304, FDA 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA.

Qualification And Education

• Bachelor’s Degree required.
• ASQ Certification preferred.
• Regulatory Affairs Certification (RAC) preferred.