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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.
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
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
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
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Medical Devices & Healthcare
Professionals 6 - 10 years of experience
New Brighton
hybrid
134273
Paid vacation time
Competitive compensation
Retirement savings plans
Wellness benefits
Sick leave
Long-term-service awards
TUV SUD Recruiting
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.