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1+ months

Sr Quality Engineer

Medtronic
Minneapolis, MN 55405
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Sr Quality Engineer

Location:

Fridley, Minnesota, United States

Requisition #:

20000LVD

Post Date:

Feb 08, 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.


**RENAL CARE SOLUTIONS** strives to improve outcomes, access, and quality of life for patients affected by renal disease.


Help streamline and speed our time to market and build quality in at every step. You will be a member of the new product development quality team that supports the design and development of innovative, new products within the RenalCare Solutions business. You can apply design controls and combination product concepts from product ideation through commercialization.Impact patient outcomes.


**Come for a Job, Stay for a Career.**


**A Day in the Life**

To provide quality engineering support in the design and development of innovative products for Renal Care Solutions through design controls planning, test method development, verification and validation. The individual shall support cross-functional development project teams and collaborate with other Medtronic and external engineering groups to ensure that new products and product changes are adequately evaluated/tested with respect to requirements and product Design History File is complete.


**Responsibilities Include:**


+ Evaluates product design and identifies potential design quality issues and drive technical decisions

+ Works within a development team to identify and implement effective controls to support the development, qualification, and commercialization of products to meet or exceed internal and external requirements.

+ Assists on-time completion of Design Control Deliverables

+ Accountable for ensuring Design Verification and Validation execution and deliverables comply with quality system regulations and internal requirements

+ Prepares risk management files and report for product releases, and has responsibility for active participation in risk management activities from product conception through commercialization

+ Supports design test and inspection method development and validation

+ Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

+ Ensures DHF and DMR content completion, integrity, and regulatory standards compliance; collaboratively communicating resolving gaps

+ Supports and ensures the establishment of objective, measurable, discrete, and verifiable customer and product requirements

+ Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

+ Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.

+ Supports in the development and maintenance of Quality Management System procedures

+ Support audits, CAPA/NCR/SCAR investigations and reports

+ Perform other related duties as assigned


**Must Have: Minimum Qualifications**


+ 4-6 years of experience with a Bachelors Degree in a technical/engineering discipline; or

+ 2-4 years of experience with a Masters Degree in a technical/engineering discipline; or

+ Medical or Pharmaceutical industry experience

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


+ Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

+ Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

+ Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

+ Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

+ Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

+ May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.


**Must Have: Minimum Requirements**


+ Bachelors degree required

+ Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience


**Nice to Have**


+ Experience designing and testing medical device preferred

+ Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance

+ Good statistical data analysis skills

+ Design for Six Sigma and Critical to Quality training and experience a plus

+ Ability to manage multiple projects across multiple geographies.

+ Excellent verbal and written skills

+ Able to work independently, as well as in a team environment

+ Experience with 21CFR820, ISO13485, and ISO14971

+ Customer focused and service oriented

+ Ability to educate stakeholders, customers and management

+ Ability to interface with internal customers, suppliers and regulatory agencies

+ Experienced working with cross-functional and international teams

+ Knowledge of FDA and TUV requirements.

+ ASQ certification a plus

+ Travel up to 20-30%


**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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.


The physical demands described within the Day in the Life 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**


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
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: 2020-12-24 Expires: 2021-03-21
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Sr Quality Engineer

Medtronic
Minneapolis, MN 55405

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