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Quality Engineer II

1 month ago

Lexington, United States FRESENIUS MEDICAL CENTER Full time

Quality Engineer II, NxStage Medical, Inc., a Fresenius Medical Care N.A. company, Lexington, Massachusetts (Remote)

Purpose and Scope:

Responsible for applying biomedical systems engineering and quality assurance principles and techniques to NxStage’s product development lifecycles, focusing on design assurance for product development projects. Will also be responsible for testing NxStage medical devices.

Principal Duties and Responsibilities:

  • Assisting in supporting biomanufacturing teams in the investigation of manufacturing problems and product complaints, helping them to determine the root cause of the malfunctions and recommending the appropriate corrective and preventive actions to prevent their recurrence;

  • Investigating and processing medical device complaints and maintaining an appropriate and manageable level of open complaints;

  • Assisting in maintaining quality system information databases, evaluating quality data and preparing periodic reports to monitor business trends;

  • Supporting Engineering in the development, testing, verification, validation and commercialization of new products;

  • Processing Non-Conforming Material Reports (NCMRs) including Material Review Board (MRB) dispositioning;

  • Enforcing design controls;

  • Assisting in developing and establishing quality systems programs and plans that ensure compliance with the Quality System Regulations;

  • Developing, implementing, and/or maintaining instructions and methods for inspecting, testing and evaluating product conformance to required specifications;

  • Reviewing and validating service bulletins, field service notices, and other documentation;

  • Reviewing service data records and ensuring their traceability;

  • Developing process improvements in cooperation with Lawrence and MediMexico (MDM) service departments;

  • Assisting with internal audits for the evaluation of compliance with the Quality System Regulations; and

  • Assisting with audits of external suppliers.

Education Experience and Required Skills:

Position requires either (i) a Bachelor’s degree (or an equivalent foreign degree) in Biomedical Engineering or a closely related field and 5 years of experience as a Quality Engineer in the medical device field or a Master’s degree (or an equivalent foreign degree) in Biomedical Engineering or a closely related field and 3 years of experience as a Quality Engineer in the medical device field. Must also have 3 years of experience (which can have been gained concurrently with the primary experience requirement above) working with the following:

  • Investigating and processing medical device product complaints;

  • ISO14971, 21 CFR Part 820 and ISO 13485;

  • Preparation of Nonconforming Material Reports and performing Root Cause Analysis and CAPAs;

  • Minitab, Gage R&R and Change Control review;

  • Risk analysis, DFMEA, Design Verification, and test method validation as well as with procedural gap analysis.

Will accept any qualified combination of education, training and/or experience.

This is a telecommuting position working from home. May reside anywhere in the United States.