Principal Quality Assurance Engineer

Medtronic. Careers with a passion for life.

 

As the world?s leading medical technology company, we provide lifelong solutions to people with chronic disease. We also are dedicated to the total well- being of our employees and have been recognized as a Fortune ?Best 100 Companies to Work For in America.? Work with the kind of people who not only love what they do but why they do it.

 

POSITION PURPOSE:

Develop, implement and improve quality systems to achieve and maintain compliance to specifications and QSR, ISO, CRM and division quality requirements.

 

RESPONSIBILITIES:

? Develop, implement and improve quality systems to achieve and maintain compliance to specifications and QSR, ISO, CRM and division quality requirements.
? Provide technical guidance to evaluate and recommend solutions to complex development issues.
? Summarize and communicate quality issues to all levels of the organization.
? Provide assistance and expertise in the implementation of statistical methods applied to process characterization, qualification and long term process monitoring.
? Lead cross-functional teams to assess design and process risks through FMEAs, Fault Tree Analyses, etc.
Participate in establishing and reviewing specifications/requirements for components, products and processes

Required by the Essential Functions:
-Lifting/Carrying 10 lbs. or more 2x/day
-Bend/Stoop/Kneel 2 hrs/day
-Stand/Sit/Walk
-Microscope/fine close work 2 hrs/day
-Vision requirements correctable to 20/20 in 1 eye and 20/40 in other eye.

Environmental Exposures:
-Chemical/Solvents
-Clean Room - Wear gloves
-Eye Protection
-Laser


 

REQUIREMENTS:

Minimal Requirements:
? Bachelor?s Degree in Engineering or Material Science
? 4-7 years Quality Assurance Engineering experience, including demonstrated skills in statistical methods, DOE?s and FMEA?s.
? Competent in the use of MS Office software, including application of Excel for data analysis
? Working knowledge of Quality Engineering Statistical Tools (DOE, ANOVA, SPC, Gage R&R)
? Experience leading cross-functional team discussions (FTA/FMEA Facilitation, etc.)
? Experience in problem solving methodologies (8-D, Root Cause Analysis, etc.)

Preferred Requirements:
? Knowledge of GMP, ISO 9001 and medical components and devices
? Clear understanding of a highly regulated business and the detailed procedures inherent to the job.
? Lean / Six Sigma skills
? 7-10 years experience with a Masters Degree in a related field
 

 

 

With people like you, who have purpose, potential and passion, we?ll supply physicians and their patients around the world with the means to extend life, restore health and alleviate pain. We currently have multiple position openings in a variety of locations.

 

TO APPLY, visit www.medtronic.com/employment/ select Requisition #51861 and ?Apply to this Job? to route your resume directly to the hiring department. No agencies or phone calls, please. Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.