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1+ months

Quality Engineer II

Medtronic
North Haven, CT 06473
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Quality Engineer II

Location:

North Haven, Connecticut, United States

Requisition #:

210000V3

Post Date:

Jan 20, 2021


**Careers that Change Lives**


**MITG**


The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less

invasive surgical solutions.


**SURGICAL INNOVATIONS** sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and

conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.


**A Day in the Life**


Perform Quality Assurance/Quality Engineering under broad direction to ensure components, finished products and processes meet established specifications. Analyze material

and processes and make recommendations/ take action to correct deficiencies.

**POSITION RESPONSIBILITIES:**

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 action taken 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/process quality

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 with 4 years of experience

+ Or an advanced degree with 2 years of experience


**Nice to Have**


Strong communication, manufacturing process, product industrialization and leadership skills

JD#: QS00003801 Rev 200 Template: QS00004883-001 Rev 200 Page 2 of 2 Last Updated: June 29, 2017

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.

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Posted: 2021-01-26 Expires: 2021-03-01
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Quality Engineer II

Medtronic
North Haven, CT 06473

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