Principal Quality Engineer

Company: Pride Health
Location: Marlborough
Posted on: March 27, 2026

Job Description:

Job Description Pride Health is hiring a Full-Time Principal Quality Engineer to support our client’s medical facility based in Marlborough, MA 01752 (hybrid). This is a 12-month assignment (possibility of extension or conversion) opportunity and a great way to start working with a top-tier healthcare organization! Work Location: Marlborough, MA 01752 Pay: $55–$69 per hour Job Title: Professional - Principal Quality Engineer - Hybrid Job Duration: 12 months (possibility of extension) Shift: 1st shift, M–F, 8–5 EST (normal business hours) Work Model: Hybrid, required 3–4 days in office in Marlborough, MA Job Description: Principal Quality Engineer - Pharma and Diagnostics Job Summary: This role ensures that Quest Diagnostics’ 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. Key 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 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 • Manage post-market incident activities (field actions, MDRs, EU incident decision/reporting, field failure trending) • Maintain knowledge of laboratory regulatory requirements, including accrediting bodies and 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, procedures, and training materials as needed • Follow corporate policies and procedures • Perform other duties as assigned Qualifications: Required Work Experience: • 8 years of experience in Medical Devices and/or In Vitro Diagnostics (IVD) • 8 years in design and development with a strong focus on design control and risk management Preferred Work Experience: • 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, 806, 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA) Knowledge: • Experience with quality management system development, Design Controls, and risk management Skills: • Strong verbal and written communication • Ability to build and manage an effective team • Ability to influence others and drive results • Effective presentation skills • Problem-solving Competencies: • Ability to influence and create change • Strong interpersonal communication skills • Strong writing and composition skills • Proven success in motivating team members to achieve objectives Business Process Skills: • Ability to drive quality improvement through problem-solving skills and knowledge of quality tools • Ability to lead and drive change • Organizational skills • Project and team management skills • Analytical and problem-solving skills • Proficiency in Microsoft Word, Excel, and PowerPoint • Ability to function in a matrix organization • Flexibility to meet continuously changing priorities and challenges • Ability to understand, interpret, and apply quality and regulatory requirements Work Environment: • Prolonged sitting at a desk (computer use, telephone, document review) • Walking or standing within the office or laboratory to operate equipment • Required to wear PPE when visiting testing locations • Frequent response to text/email communications; awareness of ergonomic principles required • May require travel by airplane/train or long-distance driving • Ability to follow verbal and written instructions and communicate effectively Education: Bachelor’s Degree (Required) Certifications: • ASQ Certification (preferred) • Regulatory Affairs Certification (RAC) INDPHCAlliedHV

Keywords: Pride Health, Portland , Principal Quality Engineer, Engineering , Marlborough, Maine