*Hi,*

*
*

*We have below requirement with one of your direct client. If you have any
matching resumes, please send me your updated resume with contact details to
[email protected]  ASAP.*

* *

*Title* :  Senior Quality Performance Engineer

*Duration* : 6+ Months

*Location* : Brooklyn Center, MN “LOCAL ONLY”



*Description* :

Completes Design History File documentation

-Determines manufacturing operation requirements and process parameters

-Develops and implements strategic plans

-Develops plans to evaluate process repeatability and stability

-Develops product and process improvements

-Performs process and equipment validations

-Provides technical support to other engineers

-Reviews product performance data to identify trends

-Generates documentation for engineering protocols and reports



*BASIC QUALIFICATIONS*:

-Proficiency with standard desktop PC tools suites.

-Communication proficiency in technical writing, verbal and presentation
skills.



*POSITION DESCRIPTION*:

-This position will lead and manage complaint investigations for Medtronic
implantable products (e.g. Implantable Pulse Generators, Implantable
Cardioverter-Defibrillators, Therapy Delivery Leads, accessories, etc).

-This includes analysis of product performance data, providing failure
analysis guidance, defining standard work, identifying trends, and
documenting complaint investigations.

-This cross-function role involves alignment and coordination across
multiple teams, including Technical Services, Product Support, Reliability,
Customer Communications, Supplier Quality, and MDR/Vigilance.



*POSITION RESPONSIBILITIES*:

-Provide leadership in assessing product performance issues arising from the
field.

-Core responsibilities require ownership of product analysis results, review
of complaint files, and initiation of investigations and CAPA. Drive
alignment between Service, Product Support, Reliability, Contact
Manufacturers, and Product Performance on complaint investigation methods.

-Collaborate with MDR on completing the complaint file for reportable
events.

-Experience working with Quality Systems and Corrective and Preventive
Action.

-Working knowledge of database query tools such as Business Objects.



*EDUCATION REQUIRED*:

-BS or higher in Engineering, Physics, Materials Science, Chemistry, or
related technical field.



*YEARS OF EXPERIENCE*:

-At least 5 years in a development or manufacturing environment, including 4
years in Quality Assurance, Reliability Assurance, medical device
manufacturing or electronics manufacturing.



*SPECIALIZED KNOWLEDGE REQUIRED*:

-Experience with data analysis including trend evaluation.

-Proficient with Minitab.



*DESIRED/PREFERRED QUALIFICATIONS*:

-Medical device Engineering experience.

-Specific knowledge of Medtronic non-implantable products.

-Experience in the area of Medical Device Compliant Handling.

-Knowledge and understanding of medical device manufacturing operations,
their systems and regulatory requirements.

-Experience working in a diverse environment, across organizational
boundaries.

-CQE or CRE certification



Thank You*,*

*Deepa Mukurala*

*Senior Business Recruiter*

*MOTORIA*

*Providing Intellectual Capital To Companies Worldwide!*

INTEGRITY | ACCOUNTABILITY | INNOVATION | COMMITMENT

MMSDC/NMSDC Certified Minority Business Enterprise (MBE)

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