Principal Quality Engineer

Title: Principal Quality Engineer- Pharma and Diagnostics Location: Marlborough MA 01752 Duration- 12 months State of Credentials Licenses Required: Bachelors degree or higher Shift/Time Zone: 1st shift M-F 8-5 EST(normal business hours) Hybrid, required 3 or 4 days in office in Marlborough MA Experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk management is preferred There is potential for this to turn into a direct role. Candidates must be open to the idea of temp to perm, pending the business needs. Job Summary This role ensures that client's 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 ResponsibilitiesDevelop, 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 productsConduct hazard analysis and risk assessments for IVD products according to ISO14971 throughout the IVD product lifecycleLead internal and external audits, including preparation, execution, and follow-up to ensure adherence to quality and client standards and regulatory requirementsOversee corrective and preventive action (CAPA) processes, non-conformance investigations and deviations to resolve quality issuesCollaborate with cross-functional product development teams to integrate quality requirements into product design, verification and validation activities according to Design ControlsReview 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 productsEstablish, monitor and analyze quality metrics, trends and performance data to identify areas of improvementSupport regulatory submissions and activities for IVD product approvalsSupport complaints process (review, process, investigate, trend quality data, etc.) and post-market incident activities.Support post-market incident activitiesManage 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's 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 dataStay current with evolving regulatory requirements, standards, and industry trendsProactively update internal processes, policies and procedures, and training materials as neededDrive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance dataStay current with evolving regulatory requirements, standards, and industry trendsProactively update internal processes, policies and procedures, and training materials as neededFollow corporate policies and proceduresPerform other duties as assigned. Qualifications Required Work Experience: 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 Preferred Work Experience: 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). Knowledge: Experience with quality management system development, Design Controls, and risk management Skills: 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 Competencies:Demonstrate ability to influence and create changeStrong interpersonal communication skillsDemonstrate strong writing and composition skillsDemonstrate success in motivating team members to reach objectives Business Process SkillsAble to effect Quality Improvement through problem solving skills and knowledge of quality toolsAble to lead and drive changeOrganization skillsProject and team management skillsAnalytical and problem-solving skillsProficient in Microsoft Word, Excel, and PowerpointAble to function in a matrix organizationFlexibility to meet continuously changing priorities and challengesRequires ability to understand, interpret and apply quality and regulatory requirements. Work Environment:Prolonged sitting at a desk (i.e., operating a computer, telephone use, document review)Walking or standing within the office area to operate other office equipment (i.e. printer / fax) or within the laboratoryRequired to wear PPE as appropriate when visiting testing locationsMust frequently respond to text/email communications and will be required to be aware of ergonomic principlesMay be required to travel by airplane /train or drive long distancesAbility to follow verbal or written instructions and use effective verbal and written communication Education Bachelor's Degree (Required) License/Certifications ASQ Certification preferred Regulatory Affairs Certification (RAC)

Created: 2026-04-04