Quality Engineer

Job description

The Quality Engineer will develop test methods and perform root cause analysis on clinically applied medical device global customer returns.  In addition, the Quality Engineer will support training of Investigation staff and work with cross functional teams to ensure current test methods are accurate and in compliance with GMP, ISO, QSR, FDA and International Regulatory requirements. This is a hands-on position and requires the incumbent to test and evaluate products.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

·  Test and thoroughly evaluate devices of various degrees of complexity through test protocol execution to determine root cause analysis within a closely monitored time frame. 
·  Identifying the appropriate test method/regiment from existing Standard Operating Procedures for complaint sample evaluation, execute the method, and interpret the data (technical) for definitive root cause analysis determination.  Test methods may include dimensional and/or tensile testing and interpretation of the technical data yielded in accordance with USP/EP/ASTM standards.
·  Design and develop tools, test systems, or test methods to be used to support product failure analysis testing. 
·  Replicate reported failure mode with bench top or in vivo test methods and document observations accordingly.
·  Prepare technical investigation reports based on results of evaluation and/or review of the manufacturing plant reports to be documented in the Department complaint database and incorporated into customer response letters.  
·  Work with the R&D, Design QA and Medical Affairs in performing such tasks as: AFMEA, DFMEA, PFMEA, and Risk Assessments.
·  Perform engineering measurement and analyses, Gauge Repeatability & Reproducibility, and Measurement Systems Analysis (MSAs) studies
·  Writes standard operating procedures and  local instructions as necessary
·  May coordinate workload and priorities for technical team members
·  May work on special projects and assignments, representing the department
·  Provide training and mentoring to Quality Engineers on product knowledge, root cause analysis, policies and procedures; in addition assists with the onboarding of new employees and temporary workers.    
·  Assist management in the coordination of Investigations to meet departmental KPIs. 
·  Monitor and report investigation metrics to ensure departmental Key Performance Indicators are met.
·  May be required to participate in customer site visits.
·  Initiate and Champion Corrective Action Requests to Manufacturing or Engineering Departments as needed.
·  Certification with OSHA’s BloodBorne Pathogens Standard 29 CFR 1910.1030 and adherence to Corporate and Local Environmental Health and Safety Policies.
·  Maintain the highest level of compliance to the Code of Federal Regulations, Medical Device Directive (European Union), Canadian Medical Device Regulations, Japan MHLW, China SFDA and Australian Regulations.  

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.

My Profile

Create and manage profiles for future opportunities.
Go to Profile

My Submissions

Track your opportunities.
My Submissions

Similar Listings

Principal Software Design Quality Engineer - Ventilation

Carlsbad, California, United States

📁Engineering

Requisition #:170001NH

Careers 2.0

Framingham, Massachusetts, United States

📁Engineering

Requisition #:16000LBK

R&D Engineer

Jacksonville, Florida, United States

📁Engineering

Requisition #:170002NY

View More Listings var jsQueue = $LAB // load and initialize jQuery (local or google cdn) .script('/jquery/jquery-1.8.3.min.js') .wait(function() { j$ = jQuery.noConflict(); window.FB = false; }) // load all global plugins .script("/plugins/jquery-ui-1.10.3.custom.min.js") .script("/plugins/json2.js") .script("/plugins/bootstrap/bootstrap-popover.js") .script("/plugins/jquery.colorbox.min.js") .script("/plugins/jquery.easing.1.3.js") .script("/plugins/jquery.history.js") .script("/plugins/jquery.detectmobilebrowser.js").wait() .script("/plugins/chosen.jquery.js") .script("/plugins/jquery.validate.js") .script("/plugins/ZeroClipboard.js") .script("/plugins/sanitize.js") // For contenteditable usability .script("/sha1.js") .script("/social_api.js") .wait(function(){ j$.easing.def = "easeInOutQuint"; j$.validator.setDefaults({ messages: { required: "This field is required.", remote: "Please fix this field.", email: "Please enter a valid email address.", url: "Please enter a valid URL.", date: "Please enter a valid date.", dateISO: "Please enter a valid date (ISO).", number: "Please enter a valid number.", digits: "Please enter only digits.", creditcard: "Please enter a valid credit card number.", equalTo: "Please enter the same value again.", accept: "Please enter a value with a valid extension.", maxlength: $.validator.format("Please enter no more than {0} characters."), minlength: $.validator.format("Please enter at least {0} characters."), rangelength: $.validator.format("Please enter a value between {0} and {1} characters long."), range: $.validator.format("Please enter a value between {0} and {1}."), max: $.validator.format("Please enter a value less than or equal to {0}."), min: $.validator.format("Please enter a value greater than or equal to {0}.") } }); })// do not end with ";" .script("/plugins/jquery.jscrollpane.min.js") .script("/jquery/jquery.autosize-min.js") .script("/plugins/jquery.uploadify-3.1.min.js") // add page specific plugins and utilities here: .wait() // do not remove // add global custom functions to the queue .script("/desktop.js?v="+TVAPP.property.version_num).wait() .script("/changePassword.js?v="+TVAPP.property.version_num) .script("/user.js?v="+TVAPP.property.version_num) .script("/login.js?v="+TVAPP.property.version_num) .script("/modal.js?v="+TVAPP.property.version_num) .script("/rfl.apply.js?v="+TVAPP.property.version_num) .script("/persona.js?v="+TVAPP.property.version_num) .script(function() { return (TVAPP.property.fb ? "/facebook/facebook_app.js?v="+TVAPP.property.version_num : null); }) .script("/facebook_status_post.js?v="+TVAPP.property.version_num) .wait(function(){ TVAPP.pageInit(); TVAPP.stateOnLoad(); j$(document).trigger('globalJSLoaded'); })// do not end with ";" // add page specific custom scripts here: .script("/video.js?v="+TVAPP.property.version_num) .script("/referral.js?v="+TVAPP.property.version_num) .script("/job_details.js?v="+TVAPP.property.version_num); // always end with ";"

·  Job Search
·  Help
·  Sitemap
© var d = new Date().getYear(); document.write((d Medtronic. All rights reserved.

Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.
Learn More

Sales

Bring life-changing solutions to those who need them. Be rewarded for rewarding work.
Learn More

Regulatory

Challenge us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.
Learn More

Read About The
Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.
Learn More

EMPLOYEE STORY:
ENGINEERING

Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.
Learn More

WONDERING ABOUT
WORKING AT
MEDTRONIC?

Our employees come from varied backgrounds with a common goal—changing lives.
Learn More

We value what
makes you
unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.
Learn More

“The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.” Emily R. - Sr Manufacturing Engineer -->
“Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.”
“Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.”
0 0 0
0 0 0

WORKING AT
MEDTRONIC

Be part of one of the world’s leading medical technologies and solutions companies.

·  Our Culture
·  Employee Stories
·  Career Growth
·  Student Opportunities
·  Diversity & Inclusion
·  Compensation and Benefits
·  Applicant Help

·  Facebook
·  Twitter
·  Youtube
·  LinkedIn
·  Medtronic.com
·  EEO Policy Statement
·  Privacy Statement
·  Terms of Use
·  Contact

var vMinLength = "6"; var vMaxLength = "30"; var vMinNonAlpha = "0"; var vUpperLowerRequired = "false"; var vMinLengthErrTxt = "Minimum number of characters in password is"; var vMaxLengthErrTxt = "Maximum number of characters in password is"; var vMinNonAlphaErrTxt = "The password must contain at least"; var vNoChangePassword = "Please fill in your new password."; var vUpperLowerRequiredErrTxt = "The password must contain at least one uppercase letter
and at least one lowercase letter."; var vNoPasswordSpace = "No spaces."; // Special groups for clients who have aditional requirements var vSpecialGroup1 = ""; var vMinSpecialGroup1 = ""; var vMinSpecialGroup1ErrTxt = "You need 1 of the following characters []."; var vSpecialGroup2 = ""; var vMinSpecialGroup2 = ""; var vMinSpecialGroup2ErrTxt = "You need 1 of the following characters []."; var vSpecialGroup3 = ""; var vMinSpecialGroup3 = ""; var vMinSpecialGroup3ErrTxt = "This is where you set the error given by special group #3"; // Error Messages - optional var vErrHeaderDefault = "Please conform to the following criteria:
"; //var vErrFooterDefault = "FieldError.PasswordErrorFooter"; var vNoLoginPasswordTxt = "Please type in your existing password."; var vJSDictCharacters = "characters."; // " characters." var vJSDictNumber = "non-alphabet character."; // " number." var vJSDictNumbers = "non-alphabet characters."; // " numbers." //"Please make sure that both of your new passwords match." var vJSDictEquality = "Passwords must match."; var vErrSubmitForm = "There was a problem submitting the form:"; // Error messages for registration page checks var vRequiredField = "Please fill in this field."; var vAtLeast = "Length must be at least "; var vValidDateRequired = "Please fill in a valid date in this field using the format mm/dd/yyyy."; var vEmailNotFormattedCorrectly = "Please provide a valid e-mail (e.g. "; var vEmailDoesNotMatchConfirm = "Your FieldMap.Member.email and FieldMap.Member.emailConfirm do not match."; var vNoConsent1 = "Please agree to the Privacy Policy."; var vNoConsent2 = "Please agree to the Terms of Service."; var vNoConsent = "Please agree to the Terms of Service."; var vAuth1or2Required = "To verify your account, please fill out FieldMap.Member.mb_auth.auth_info1 or FieldMap.Member.mb_auth.auth_info2 with at least 4 characters."; var vRegistrationSubmit = "FieldError.RegistrationSubmit";
function setGaRelationship() { var ga_relationship_name = 'unaffiliated'; return ga_relationship_name; } function setGaReferrer(){ var ga_referrer_relationship; ga_referrer_relationship = 'No referrer'; return ga_referrer_relationship; } var _gaq = _gaq || []; var ga_relationship = setGaRelationship(); var ga_referrer = setGaReferrer(); _gaq.push(['_setAccount', 'UA-77302915-1']); // Site Specific Tracker _gaq.push(['_setVar',"Relationship: " + ga_relationship + " | " + ga_referrer]); _gaq.push(['_setCustomVar',1,'Relationship',ga_relationship,3]); _gaq.push(['_setCustomVar',2,'Referrer',ga_referrer,3]); _gaq.push(['_trackPageview', window.location.pathname]); _gaq.push(['aggregate._setAccount', 'UA-19128950-12']); // Aggregate Tracker _gaq.push(['aggregate._setDomainName', '.selectminds.com']); _gaq.push(['aggregate._setVar',"Relationship: " + ga_relationship + " | " + ga_referrer]); _gaq.push(['aggregate._setCustomVar',1,'Relationship',ga_relationship,3]); _gaq.push(['aggregate._setCustomVar',2,'Referrer',ga_referrer,3]); _gaq.push(['aggregate._trackPageview', window.location.pathname]); var ga_alert = ""; if(ga_alert == "yes") { alert('Page View: ' + window.location.pathname + ' | Relationship: ' + ga_relationship + ' | Referrer: ' + ga_referrer); } (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = (' https:' == document.location.protocol ? ' https://ssl' : ' http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); function asTrackPageview(url_name) { var ga_relationship_name = setGaRelationship(); var ga_referrer_relationship = setGaReferrer(); _gaq.push(['_setCustomVar',1, 'Relationship', ga_relationship_name, 3 ]); _gaq.push(['_setCustomVar',2, 'Referrer', ga_referrer_relationship, 3 ]); _gaq.push(['_setVar',"Relationship: " + ga_relationship_name + " | " + ga_referrer_relationship]); _gaq.push(['aggregate._setCustomVar',1, 'Relationship', ga_relationship_name, 3 ]); _gaq.push(['aggregate._setCustomVar',2, 'Referrer', ga_referrer_relationship, 3 ]); _gaq.push(['aggregate._setVar',"Relationship: " + ga_relationship_name + " | " + ga_referrer_relationship]); if(ga_alert == "yes") { alert('Page View: ' +url_name + ' | Relationship: ' + ga_relationship_name + ' | Referrer: ' + ga_referrer_relationship); } _gaq.push(['_trackPageview', url_name]); _gaq.push(['aggregate._trackPageview', url_name]); //alert("Tracking Page: " + url_name); } function asTrackEvent(category, action, opt_label) { var ga_relationship_name = setGaRelationship(); var ga_referrer_relationship = setGaReferrer(); if(ga_alert == "yes") { alert('Event: ' +category +"."+ action +"."+ opt_label + ' | Relationship: ' + ga_relationship_name + ' | Referrer: ' + ga_referrer_relationship); } _gaq.push(['_trackEvent', category, action, opt_label]); _gaq.push(['aggregate._trackEvent', category, action, opt_label]); // alert("Tracking Event: " + category + " | " + action + " | " + opt_label); }

1 0

Desired profile

QUALIFICATIONS:

·  B.S. degree required preferably in a Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Software or related field.
·  Minimum three (3) test/quality engineering or closely related experience in medical devices.
·  Time management skills.
·  Critical independent thinking and timely follow up.
·  Excellent written and verbal skills necessary.
·  Strong operating knowledge of Word, Excel and PowerPoint computer applications
·  Knowledge of quality control concepts desirable
·  Detail oriented and highly organized
·  Demonstrated ability to communicate clearly both verbally and in writing 
·  Knowledge of engineering documentation, test protocols, and laboratory procedures.
·  Ability to lead or participates in team decision making, development and communications.
·  ASQ certified Quality Engineer or other relevant professional certification preferred.