Principal Quality Engineer

Job Description: This role ensures that client 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 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 policies.Proactively 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 trendsFollow corporate policies and procedures Qualifications Bachelor's Degree (Required) or higherASQ Certification preferredRegulatory Affairs Certification (RAC)8+ years of experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk managementExperience in working effectively in an FDA-regulated environmentExperience working with IVD productsAnalytical mindset with attention to detail and a commitment to integrity, product safety, and QualityDemonstrated 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 managementCommunication (verbal and written), ability to build and manage an effective team, being able to influence others and drive for results, effective presentation skills, problem solvingDemonstrate ability to influence and create changeDemonstrate strong writing and composition skillsDemonstrate success in motivating team members to reach objectivesAble 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.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 communicationExperience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk management is preferredShift/Time Zone: 1st shift M-F 8-5 EST(normal business hours) Benefits: Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics. Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st. Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification. Synectics is an equal opportunity employer.

Created: 2026-04-02