Principal Quality Engineer

Principal Quality Engineer Job Location: Plymouth, MN Job Type: Full-Time Rate of Pay: $169,166 - $179,315 Job Code: A011.7224 Closing Date: 7/7/2026 Job Duties Establish and maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including FDA and other applicable global regulatory requirements. Develop and establish effective quality control and associated risk management plans for products. Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, DOE) to promote risk reduction and control. Work with cross‑functional groups in support of new product and process development projects. Participate in New Product and Process Development and Introduction (NPD/NPI) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with company Quality System policies, procedures, standards (FDA, ISO 13485) and other worldwide regulatory agencies. Support Life Cycle Management activities (IQ/OQ/PQ) and product quality investigations. Serve as subject matter expert on all quality tools. Write, review, and/or approve process and product validation protocols and reports, equipment qualifications (IQ, OQ, PQ, TMV), and engineering change orders. Direct Failure Mode and Effects Analysis activities for both Design and Process FMEA’s. Ensure that development activities follow design control requirements, product is tested per applicable standards, and product is properly transferred to manufacturing. Provide all planning necessary to ensure effective product acceptance, including but not limited to inspection instructions, equipment and gage requirements, and sampling plans. Participate in MRB review of nonconforming product, recommend disposition and corrective action, and initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate. Participate in design reviews and pre‑validation assessments to ensure the safe and environmentally sound start‑up of new processes. Assist Regulatory Affairs in developing submissions for new devices as necessary. Make decisions independently on engineering problems and methods. Represent the organization in conferences to resolve important questions, plan and coordinate work, and represent Quality Engineering function during regulatory inspections. Recommend issue resolution to senior management for significant capability and compliance issues. Requirements Employer will accept a Bachelor’s degree in Mechatronics Engineering, Manufacturing Engineering, or related field and six years of experience in the job offered or in a Principal Quality Engineer‑related occupation. EEO Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. Benefits Vacation – 120 hours per calendar year Sick time – 40 hours per calendar year (48 hours for employees in Colorado, 56 hours for employees in Washington) Holiday pay, including floating holidays – 13 days per calendar year Work, Personal and Family Time – up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52‑week rolling period Volunteer Leave – 32 hours per calendar year Military Spouse Time‑Off – 80 hours per calendar year Eligibility for company consolidated retirement plan (pension) and savings plan (401(k)) and long‑term incentive program Eligibility for medical, dental, vision and time‑off benefits, plus those provided under the applicable Collective Bargaining Agreement #J-18808-Ljbffr 6010-Biosense Webster Inc. Legal Entity