Principal Quality Engineer

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POST DATE 9/10/2016
END DATE 10/10/2016

Atterro Eden Prairie, MN

Company
Atterro
Job Classification
Full Time
Company Ref #
254379
AJE Ref #
576130437
Location
Eden Prairie, MN
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
Job Description:

Ware is searching for a Principal Quality Engineer to be a part of a verification and validation team for manufactured products. This is a fantastic opportunity with an established medical device company located in the south west metro. Ideal candidates will have 5+ years experience with Quality Systems within the medical device industry, strong statistics/data analysis skills and hold a Black Belt.

-Provide strategic direction, planning and support related to Verification and Validation Engineering for sustaining and development projects.
-Participate in and approve Verification and Validation (V&V) protocols and reports in support of new product development and sustaining for all owned products.
-Oversee the development and implementation of standards, methods, and procedures for development activities and sustaining engineering projects as it applies to V&V Testing.
-Provide ongoing mentorship and learning to other Quality Engineers on an as needed basis.
-Review and approve change orders related to updated standards and impact to development and sustaining systems.

Requirements:
-Bachelor of Science degree or higher in Engineering or Physical Sciences
-5+ years of Quality Engineering experience in medical device industry
- Ability to work seamlessly across various departments
-Working knowledge of process validation, test method validation and R&R study
-Experience with ISO 13485 quality system requirements and FDA quality system regulations 21CFR 820.
-Strong statistical / data analysis background. Experience with Minitab preferred.
-Demonstrated project management skills in order to plan, conduct and implement system assessments
-In-depth product development knowledge
-Ability to effectively lead teams and drive results

Key Words:
R&D Quality, product quality, quality systems, Black Belt, statistics, Minitab, verification and validation, medical device.

About Atterro

EQUAL OPPORTUNITY EMPLOYER

Atterro supports affirmative action and equal employment opportunity. Atterro will provide equal employment in employment practices to all associates and applicants for employment. Employment decisions shall be made without regard to any protected characteristic such as, but not limited to, race, color, religion, gender, age, disability, national origin, ancestry, gender identity, sexual orientation, marital status, status in regard to public assistance, disabled veterans, recently separated veterans, Armed Forces service medal veterans and other protected veterans, genetic information and other legally protected classes. Furthermore, Atterro is an E-Verify employer. Information provided on this application will not be used for any discriminatory purposes. Atterro complies with all applicable federal, state and local non-discrimination laws and regulations. Atterro will provide reasonable accommodations in the application or interviewing process. If you need a reasonable accommodation in the application or interviewing process, please contact us.