Principal Quality Engineer

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Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Plymouth, Minnesota, United States of America

Job Description:

Employer:

Biosense Webster, Inc.

Job Title:

Principal Quality Engineer

Job Code: A011.7224

Job Location:

Plymouth, MN

Job Type: Full-Time

Rate of Pay: $169,166 - $179,315

Job Duties:

Establish and maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including FDA and all 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 Processes 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, and other applicable standards as pertain to medical devices.

Support LCM 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, and to 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 6 years of experience in the job offered or in a Principal Quality Engineer-related occupation.

This job posting is anticipated to close on 7/7/2026.

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…