What are the responsibilities and job description for the UCB Technical Reviewer position at TÜV SÜD America?
*** This is a Remote position ***
Roles and Responsibilities:
- Perform technical assessments of audit and project files with certification decision (final review) based on requirements from ISO 13485, ISO 9001, MDSAP, AIMDD/MDD/IVDD, MDR/IVDR; ISO 17021 and relevant guidance documents e.g. IMDRF N3.
- Answer internal and external requests regarding regulatory requirements.
- Keep quality records of each audit package including notes supporting the certification decision.
- Continuously look for improvement in processes and software solutions – identify, champion, and maintain said improvements.
- Keep abreast of present and pending regulatory requirements, standards, and TÜV SÜD America service capabilities through e.g. TÜV SÜD or internal training, external seminars, conferences, trade shows, participation in technical or subject matter relevant work/interest groups, reading of scientific articles.
- Generate metrics as required.
- Support data collection and analysis of certification processes, ensuring that certification (quality and regulatory) requirements are considered.
- Handle contract review and audit registration, as required.
- Apply Good Documentation Practices to ensure data and document integrity.
- Handle and process confidential client documentation; tasks include labeling, uploading, archiving, documenting, and quality control of electronic files/folders according to written or verbal instructions.
- Ensure compliance and conformity with established policies and procedures.
- Meticulous and uncompromised attention to requirements and quality of work.
- Create and update QMS documents ensuring accuracy and validity of the information.
- Communicate in a prompt, courteous and effective manner with internal and external customers in all circumstances including providing information, answering questions, and relaying messages.
- Maintain trusting relationships with colleagues.
- May function as Process Expert representing a particular process step in the CB (e.g., Final Review, Admin Review, Contract Review, and Audit Registration, etc.) based on acceptable performance.
Other tasks as needed.
Education and Qualifications:
- Bachelor’s Degree in engineering, regulatory, quality, science, health, or related and
- Formal training in Corrective and Preventive Actions, and Root Cause Analysis
- Lead Auditor Certification (including surveillance and (re)certification audits performed).
- 5 years industrial medical device experience, at least 3 of them as Quality Manager / Project Manager / Engineer / Regulatory Affairs / Quality Assurance or related or
at least 18 months as Certification Specialist plus 18 months Certification Associate.
- 2 years auditing experience to all or some of ISO 13485, MDD/IVDD/AIMDD, CMDCAS, MDSAP, MDR/IVDR.
- Experience working for an accredited Certification Body is preferred.
- Demonstrated high level of performance.
- Hands-on knowledge about Good Documentation Practices (particularly electronic and digital documents) and quality management methods/techniques
Knowledge and Skills:
- IT fluent (i.e. MS Products and other common software products/tools).
- Demonstrated ability to work alternating between independently, in a collaborative team environment and under supervision.
- Demonstrated, excellent oral and written communication skills.
- Self-starter with a positive outlook and motivated attitude; a commitment to self-improvement.
- Familiar with risk management, project/program management, and quality assurance process engineering.
- Ability to successfully keep track of several projects at one time, adhere to tight deadlines and maintain a positive, helpful attitude.
- Represent TÜV SÜD products and services in a professional manner.
- Accurate, clear, and timely communication of information, upward and lateral, including very good verbal, written, and listening skills.
- Reliable judgment that is consistent, adaptable to unusual situations, realistic, mature, a commonsense approach to job and problems.
- Willingness to consider other’s ideas and to work with others as part of a team.
- Adaptable and willing to shift to other duties to meet changing workloads.
- Values that include a high standard of ethics and integrity, ability to trust and be transparent/truthful.
- Passion for working in the medical device and TIC industry.
This job specification should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions and perform any other related duties as may be required.
MATERIAL AND EQUIPMENT DIRECTLY USED:
- General office equipment; telephone, personal computer, printer, copier, scanner, and other communication tools.
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: Labor Law Posters
