Senior Certifications Coordinator

Performs essential tasks required for TÜV SÜD to provide accurate and complete certification decisions and results to clients and regulators. Position includes interfacing responsibilities with internal and external customers. The successful candidate is detail-oriented, enthusiastic, able to work with minimal supervision, and knowledgeable regarding applicable regulatory requirements, with a problem-solving mindset.

Roles and Responsibilities: 

- Collaborate with UCB and global Operations personnel to facilitate timely, compliant audits and certifications.

- Perform review and approval of client applications including technology and product code selection, audit registrations, administrative data, and/or certificate data, as assigned by Team Lead.

- May support the Authorization Competency Qualifier by performing Pre-Authorization Quality Review of auditor authorization requests.

- Utilize Good Documentation Practices to ensure data and document integrity.

- Collect and generate metrics and statistics related to the certification process.

- Provide support to internal and external stakeholders by adhering to applicable standards, regulations, and internal policies and procedures.

- Create and/or update existing department procedures and forms.

- Ensure that requirements related to certificate scope, validity period, and other technical aspects are met.

- Review audit documentation both pre-and post-audit to ensure compliant audits are performed and certification requirements are met.

- Handle and process confidential client documentation.

- Provide integral input to the Global Process Owners and Compliance Analysis Process Specialist (CAPS) in consideration of QMS processes

- Communicate in a prompt, courteous and effective manner with internal and external customers in all circumstances including providing information, answering questions, and participating in problem   resolution.

- Continuously look for improvement opportunities within UCB processes.

- Function as process subject matter expert representing a particular process step in the CB (e.g., REPs uploads, file archiving, auditor authorization, etc.) based on demonstrated expertise.

- Support external audits (SCC/MDSAP) in relation to job activities / Other tasks as needed.

Required Skills:

- High level of computer literacy including proficiency with MS Office products and remote communication tools.

- Demonstrated ability to independently manage several projects at one time, adhere to tight deadlines, and maintain a collaborative team attitude.

- Accurate, clear, and timely communication of information, upward and lateral, including verbal, written, and listening communication skills.

- Reliable judgment that is consistent, adaptable to unusual situations, realistic, taking a risk-based approach to challenges.

- Willingness to consider other’s ideas and participate in problem-solving activities.

- Adaptable and able to shift to other duties to meet changing workloads.

- Values include a high standard of ethics, integrity, and transparency.

- Ability to comprehend and perform critical tasks and their consequences.

- Passion for working in the medical device industry.

Required Education and Qualifications:

- Associate degree or advanced coursework in engineering, regulatory, quality, science, health, or related field required; Bachelor’s degree preferred.

- Comprehensive understanding of quality management system practices and standards, regulatory requirements,  normative documents, and legal framework for the certification body (ex: ISO 9001, 13485,   14971, and 17021-1; MDSAP Audit Approach; IMDRF N3 and N4, etc.)

- Understanding of certification body processes and organization.

- Understanding of audit practices, audit time calculation, and required audit team competence.

- Hands-on knowledge of Good Documentation Practices (particularly electronic and digital documents) and quality management methods/techniques related to documentation and records as well as data and   information (e.g. safeguarding, labeling, confidentiality, and protection).

- Minimum 3 years office experience or equivalent experience in a professional environment.

- Minimum 2 years of experience in the medical device, manufacturing, medical, or pharmaceutical industry.

- Auditing experience preferred / ASQ Certification preferred.

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=27