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Quality Engineer


Waltham, Massachusetts | Concord, California

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Job ID JR0000207
POSITION FEATURES:

Quality Engineer, Fresenius USA, Inc., a Fresenius Medical Care N.A. company, Concord, California


Purpose and Scope:

Responsible for providing assistance in performing disciplined problem solving for supplier, customer, and internal quality defect. Maintains knowledge of all products, processes, and basic quality principles required to assist with daily operations and continual improvement activities.

Principal Duties and Responsibilities:

        • Understanding the technical aspects of the company including supplier products and processes in order to drive quality improvements and communicate them clearly to the customer.
        • Investigating root cause solutions for product release through nonconformance reports (NCR), corrective and preventative actions (CAPA), material containment and holding forms (MCH) and affected lot hold forms (ALH).
        • Working directly with quality improvement tools and other various quality techniques.
        • Providing support to all departments regarding product quality, inspections, deviations and disposition of non-conforming product.
        • Recommending measures necessary to prevent a recurrence of defects to manufacturing, engineering, supply chain and other departments as needed.
        • Analyzing reports and data in support of in-house process improvements, corrections, and corrective actions as a means of continual improvement.
        • Continuously assessing current publications, standards and regulations in order to stay up to date with quality projects, material issues, sterilization processes through training.
        • Escalating issues to supervisor/manager for resolution, as deemed necessary.

Education Experience and Required Skills:

This position requires a Master’s degree (or equivalent foreign degree) in Industrial and Systems Engineering, Mechanical Engineering, Electrical Engineering or closely related field and 1 year of experience performing quality engineering in support of medical device products or, alternatively, a Bachelor’s degree (or equivalent foreign degree) Industrial and Systems Engineering, Mechanical Engineering, Electrical Engineering or closely related field and 3 years of experience performing quality engineering in support of medical device products. Experience, which may have been gained concurrently with the primary experience requirement above, must include 1 year of experience: (i) utilizing verification procedures and quality compliance tools to evaluate materials and process flow in the development of standard protocols; (ii) Using nonconformance reports (NCR), corrective and preventative actions (CAPA), material containment and holding forms (MCH) and affected lot hold forms (ALH) to investigate root cause solutions for product releases; (iii) working directly with validation and quality improvement tools to ensure adherence to quality assurance standards (including IQ, OQ, and PQ); and (IV) familiarity with correlation and regression analysis, experimental design (DoE), and acceptance sampling, as well as conducting and interpreting Gage R&R studies. 

This position requires 10% domestic travel.

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