Operations Quality Engineer

Job description

POSITION DESCRIPTION:
The Operations Quality Engineer will provide Quality Engineering support and leadership for the cleanroom manufacturing of Neurovascular medical devices. He/She will be responsible for providing guidance and implement strategies for driving product quality and continuous improvement, ensuring products are manufactured in accordance to applicable industry standards, regulatory requirements, and customer requirements. As a key leader in the engineering team, this person may oversee and coordinate the activities of junior quality engineers and technicians to drive timely and effective solutions.

POSITION RESPONSIBILITIES:
•Troubleshoot equipment and process issues. Summarize and draw conclusions from test results leading to effective technical resolution of process problems. 
•Disposition of non-conforming material requiring advanced process/technical knowledge. 
•Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts). Implement corrective and preventative actions. 
•Interface with Production, Manufacturing/Process Engineering, R&D, and Regulatory departments to resolve process issues and implement changes. 
•Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line. 
•Identify, analyze, and manage risk through product life cycle with use of FMECA and other risk management tools. 
•Provide training, leadership, and guidance for junior quality engineers and/or technicians. 
•Other duties as assigned or required. ABOUT MEDTRONIC:
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. 
We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. 
PHYSICAL JOB  REQUIREMENTS:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EEO STATEMENT:
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees 
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Desired profile

BASIC QUALIFICATIONS:
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME 
•Experience in a regulated manufacturing environment and troubleshooting product and manufacturing processes 
•Knowledge of basic quality tools, risk analysis, statistics 
•Ability to read and understand engineering drawings 
•Knowledge of Quality System requirements, ISO and FDA requirements (preferred)

REQUIRED EDUCATION: 
•Bachelor of Science degree in Engineering (Mechanical, Biomedical, or Materials preferred) with 2+ years of related professional work experience. 
•Experience in medical device industry is preferred. 

REQUIRED YEARS OF EXPERIENCE:  
•2+ years is preferred

REQUIRED KNOWLEDGE: 
See above in “Basic Qualifications”