Quality Engineer II

Location:

North Haven, Connecticut, United States

Requisition #:

21000HVL

Post Date:

Mar 28, 2022


**Careers that Change Lives**


**A Day in the Life**

**Responsibilities may include the following and other duties may be assigned.**


1. Evaluate compliance of materials and/or processes with specification and customer requirements


2. Collect, analyze, interpret and summarize statistical data


3. Perform defect analysis on components and finished goods


4. Create validation protocols, summaries, and approvals


5. Initiate corrective action requests on discrepant product/processes and verify adequacy and accuracy of corrective actiontaken internally and/or externally


6. Assist in Design of Experiments to improve process/product


7. Assist other functions in the timely disposition of material to support operational objectives


8. Perform analyses and provide reports to management


**Department Specific/Non-Essential Functions:**


1. Assist suppliers in developing inspection methods


2. Perform Gage RR and correlation studies


3. Work with QA Technicians to resolve measurement and testing issues


4. Work with QA departments to resolve blueprint/specification issues


5. Work with other departments to resolve issues related to material and process quality, including FMEA, DOE, SPC


6. Develop Control Plans, Inspection Instructions and other documents as needed to effectively manage product/processquality


7. Develop and review documented operating procedures associated with material inspection or processes


8. Work directly with suppliers to prevent or correct discrepant material


9. Compile and issue monthly reports to management


10. Assign primary responsibilities and tasks to QA department


11. Other duties as assigned with or without accommodation


12. Support CAPA activities


**Must Have: Minimum Requirements**


+ Bachelors degree required

+ Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience


**Nice to Have**

Strong communication, manufacturing process, product industrialization and leadership skills


Solid design, troubleshooting and presentation skills


Strong project management skills


Well versed in molding, stamping and machining methods.


Tooling and processing experience a plus.


Experience in assembly equipment technologies


Working Knowledge of Six Sigma


Working knowledge of GDT


Working knowledge of DFMEA, PFMEA , and Risk Tools


Working knowledge of DFA/ DFM principles


Analyze and chart statistical and process data using Minitab, MS Excel, or equivalent


Working knowledge of 21CFR820, ISO13485, Canadian MDR and MDD 93/42/EEC


Knowledge of validation process protocol creation and summaries


Proficient in Project Management


Product development process


ASQ certification or equivalent is desirable


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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.