Quality Engineer, Post Market

Overview

The Quality Engineer, Post Market at Cook Incorporated serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and / or CAPA.

Responsibilities

• Perform work per external and internal quality standards
• Interface with internal and external groups on quality-related issues
• Support product development and transfer to manufacturing
• Facilitate development and implementation of production controls. (e.g. qualification, process capability, sampling plans, validation, etc.)
• Perform investigation of product non-conformance / complaints, root cause analysis, monitoring / trending of process and product, and escalation of identified issues
• Plan, review, and approve change requests
• Execute risk assessment as needed and facilitate development and completion of risk file documentation
• Conduct risk-based decision making and effective resolution of issues
• Lead or support CAPAs as necessary
• May interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.)
• Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs
• Provide leadership in the understanding of medical device regulations and best practices
• Manage conflict resolution as it relates to technical situations
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements

Qualifications

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Physical Requirements

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Refer

Cook is an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class. Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state / province and local law.

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