Global Process Owner - Auditing

TÜV SÜD America Inc., a global leader in testing, inspection, and certification, has an immediate opening for a Global Process Owner - Auditing based in a remote position in the United States or Canada.

Your responsibilities will include but are not limited to:

• Overall responsibility for the global audit process
• Ensures process efficiency, setting the metrics/KPIs
• Monitors and measures the audit process
• Implements regulatory and normative requirements
• Ensures compliance with processes on corporate and division level
• Plans and introduces respective process
• Training on the process and its changes
• Defines interfaces between adjacent processes
• Defines process boundaries and synergies, harmonizing processes globally
• Ensures complete and correct documentation of the process
• Where appropriate, attendance at notification and accreditation audits in respect to process including follow-up of related corrective actions
• Process related documentation release is delegated from BUM
• Manages continuous improvement of process

This job may be for you if:

• Possess a BS or MS Degree in a science-related field (biotechnology, biology, chemistry, microbiology, electrical engineering, mechanical engineering, etc.)
• At least 2 years of experience performing regulatory audits of clients per European Medical Device Directives (IVDD, MDD, AIMD) and new Regulations (IVDR, MDR), Medical Device Single Audit Program (MDSAP), and international quality system standards (e.g., ISO 13485, ISO 14971)
• Practical experience in change management, project management, and process development is a plus
• A broad base of medical device technologies, including sufficient experience relevant to medical device conformity assessment, the medical device industry and the design and manufacture of devices preferable
• Sound knowledge of Union medical devices legislation and relevant guidance documents (e.g., MDR, IVDR, MDD (93/42/EEC), MDCG, and other related requirements)
• Sound knowledge of other applicable standards, required documents, and guidance documents, e.g., ISO 17021, ISO 19011, ISO 17065, IMDRF/MDSAP documents, IAF MD/ID documents, ISO 13485, ISO 9001, and MDSAP audit approach
• Sound knowledge of the notified/certification bodies’ quality management system, related procedures, and the required qualification criteria
• Training and experience in conformity assessment activities
• Understanding of continuous improvement concepts including Six Sigma, Lean, and value stream mapping
• Proficient in the use of Microsoft Office, including Project, Visio, Word, Excel, Outlook, and PowerPoint
• Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of partners, senior managers, and subject matter experts
• Strong analytical, project, and product management skills, including a thorough understanding of how to interpret business needs and translate them into operational requirements
• Ability to identify problems at an early stage and solve them effectively
• Well-developed listening, communication, and decision-making skills
• Ability to influence people from different levels of the organization

Equal Opportunity Employer – Disability and Veteran

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.

For more information on applicable equal employment regulations, please refer to the following: https://653988.extforms.netsuite.com/app/site/hosting/scriptlet.nl?script=70&deploy=1&compid=653988&h=6d5262aa43dfefb771d6&customerId=848956&token=27585917

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