Overview

The Manufacturing Quality Engineer serves as the lead quality representative of assigned product lines for new product development, day to day manufacturing support, non-conformance, and acts as the independent review function. The Manufacturing Quality Engineer supports additional process such as Supplier Quality, Internal Audit, CAPA, and Post Market Surveillance. The Manufacturing Quality Engineer fulfills the role of both contributor and independent reviewer for their assigned product lines.

Responsibilities

- Perform work per external and internal quality standards.- Perform independent review function per external and internal quality standards.- Interface with internal and external groups on quality-related issues.- Be the voice of quality for daily manufacturing in assigned departments by partnering with Operations and Production Engineering and providing guidance on issues in line with external standards, internal standards, and best practices.- Support product development and transfer to manufacturing.- Facilitate development and implementation of production processes and controls. (e.g. qualification, process capability, sampling plans, validation, etc.)- Assist with investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues.- Own quality improvement tasks in assigned departments.- Plan, draft, and route change requests as necessary.- Execute risk assessment as needed and facilitate development and completion of risk file documentation.- 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 engineering, production, clinical, and regulatory affairs.- Provide leadership in the understanding of medical device regulations and best practices.- 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 ensure compliance to FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.- Must strictly adhere to safety requirements.- Maintain regular and punctual attendance.- Must maintain company quality and quantity standards.- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.- Ability to remain calm and receptive in fast paced situations.

Qualifications

- Bachelors degree in engineering or scientific discipline- >2 years of engineering experience. Any engineering discipline if coming from a medical device background -OR- quality engineering experience from any regulated industry.- Knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971) is preferred but will consider a candidate with quality experience from any regulated industry.- Professional certification (e.g. ASQ, Six Sigma, etc.) preferred.- Proficiency in statistical, quality and continuous improvement methods and tools.- Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required.