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Job Details

Sr Quality Engineer


Bangalore, Karnataka, India

Requisition #:


Post Date:

Jan 04, 2021


**Careers that Change Lives**

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 concepts from product ideation through

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 identifiespotential design quality issues and drive technical decisions

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

+ Assists on-time completion of DesignControl Deliverables

+ Accountable for ensuring DesignVerification and Validation execution and deliverables comply with qualitysystem regulations and internal requirements

+ Prepares risk management files and reportfor product releases, and has responsibility for active participation inrisk management activities from product conception throughcommercialization

+ Supports design test and inspectionmethod development and validation

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

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

+ Supports and ensures the establishment ofobjective, measurable, discrete, and verifiable customer and productrequirements

+ Apply sound, systematic problem-solvingmethodologies in identifying, prioritizing, communicating, and resolvingquality issues.

+ Assure in the development and executionof streamlined business systems which effectively identify and resolvequality issues.

+ Supports in the development andmaintenance of Quality Management System procedures

+ Support audits, CAPA/NCR/SCARinvestigations and reports

+ Perform other related duties as assigned

**Must Have: Minimum Qualifications**

+ 5-7 years of experience with a Bachelors Degree in atechnical/engineering discipline; or

+ 3-5 years of experience with a Masters Degree in atechnical/engineering discipline; or

+ Medical or Pharmaceutical industry experience

**Nice to Have**

+ Experience designing and testing medicaldevice preferred

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

+ Good statistical data analysis skills

+ Design for Six Sigma and Critical toQuality training and experience a plus

+ Ability to manage multiple projectsacross multiple geographies.

+ Excellent verbal and written skills

+ Able to work independently, as well as ina team environment

+ Experience with 21CFR820, ISO13485, andISO14971

+ Customer focused and service oriented

+ Ability to educate stakeholders,customers and management

+ Ability to interface with internalcustomers, suppliers and regulatory agencies

+ Experienced working with cross-functionaland 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.
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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