Quality Specialist
New Brighton, MN 
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Posted 14 days ago
Job Description

At TUV SUD we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TUV SUD.

Established more than 150 years ago in Germany, TUV SUD is a leading global provider of technical services with more than 25.000 highly skilled employees across 1,000 offices worldwide. For over 30 years, throughout 33 locations, it is TUV SUD America's priority to create a safer future. To protect people, property and the environment from technology-related risks; we drive consumer protection, digital transformation, sustainable development, and urbanization.

Quality Specialist
Your tasks

The Regional Quality Specialist (Medical & Health Services) is responsible for a variety of quality-related tasks for the Medical & Health Services business unit including customer feedback (including complaint handling), CAPA management, internal audits and management review. This role is required to regularly present and provide key quality data to regional and divisional management.

Roles and Responsibilities

Primary point of contact for customer feedback (complaints and positive feedback)

Track, manage and report on CAPA status

Upon request from regional or divisional quality teams, participate in internal audits

Preparation of data for management review meetings

Participation in root cause analysis and risk analysis

Initiation and coordination of improvement measures including kaizen programs

Leading internal communication on quality programs

Other duties as assigned by management

Your qualifications

Knowledge and Skills

Experience with auditing according to either medical device standards (13485 etc) or certification body standards (17021 etc)

Good analytical and conceptual skills; knowledge in the field of data analysis/processing

Willingness to learn

Knowledge of the following is beneficial: ISO 17021-1(-3), IAF MD 9, IAF MD 7, IMDRF/MDSAP N3, IMDRF/MDSAP N4

Education and Qualifications

BS Degree in a science related field (biotechnology, biology, chemistry, microbiology, electrical engineering, mechanical engineering, etc.)

Formal training or qualification in Quality Assurance or Quality Management

Desirable: Formal training or qualification in complaint handling, customer service, or the like

Additional Information

TUV SUD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.

For more information on applicable equal employment regulations, please refer to the following:

EEO is the Law Poster: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Poster Supplement: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Details
Employment type

/

Job category

Medical Devices & Healthcare

Required experience

Professionals 6 - 10 years of experience

Organizational unit

Job location

New Brighton

Work models

hybrid

Reference number

134273

Paid vacation time

Competitive compensation

Retirement savings plans

Wellness benefits

Sick leave

Long-term-service awards

Contact

TUV SUD Recruiting

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Find out more about TUV SUD


TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
6 to 10 years
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