Audit Quality Coordinator

Joining TÜV Rheinland means working for one of the world’s leading testing, inspection, and certification service providers with more than 20,000 employees globally. Our employees are our most important asset. That is why we invest in their development and offer competitive pay, multiple health insurance plan options, and a 401(k) with up to 6% company match. At the same time we live an international, team-oriented culture characterized by respect, collegiality and openness. This enables our employees to develop their potential, apply new knowledge and methods directly - and plan a long-term career with real opportunities for advancement.

SUMMARY:

The Quality Coordinator is responsible for ensuring ISO 17021 is fully implemented and compliance with related medical regulations (MDSAP, ISO 13485, MDR, IVDR). They act as lead in both internal and external audits, coordinating management of appeals, vigilance cases, complaints, and ensuring compliance of current employees with training and qualification.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Fully implement ISO/IEC 17021, MDSAP, and HSE standards throughout Medical Audit operations and all supporting units.
• Collaborate with Manager to define missing processes to comply with ISO /IEC 17021, HSE policies or global procedures. Support with implementation, as needed.
• Represent the organization for internal and external audits. Lead contact and responsible for preparation, management, and follow-up on actions.
• Responsible for input information into corporate databases for document control, corrective and preventive action, evaluate its effectiveness, opportunities for improvement, and complaint management on behalf organization.
• Responsible for management review. Report to local management the status of current quality management system including KPIs, management review’s agreements, validity of results, and internal audits.
• Work with the team leaders and management to detect quality problems and identify and recommend corrective actions. Provide guidance on the interpretations of Standards requirements, and changes to processes and procedures to meet those requirements.
• Coordinate and be main local contact for internal and external audits.
• Ensure new documents to be uploaded to the document control system meet all the requirements for the approval process, including validation evidence as required.
• Ensure report templates meets the ISO 17021 requirements and company’s policies.
• Collaborate with the Regional Quality Manager, Business Stream Products Quality Managers and Business Quality Representatives in developing and implementing company-wide policies and procedures.
• Disseminate information to Medical Audit staff.
• Plan, manage and follow-up on training requirements for staff, including those related to (re)qualification.
• Ensure quality requirements are met including root cause analysis, follow up on customer feedback, proficiency testing and internal audits along the other ISO 17021 and HSE requirements.
• Promote a continuous process improvement culture.
• Hands-on support for the management upon request.
• Perform other duties as assigned.

QUALIFICATIONS & REQUIREMENTS:

Knowledge, Skill, & Abilities

• Strong knowledge of ISO 17021
• Deep working knowledge of Salesforce or similar tools
• Ability to work independently, act as project owner, and get results from colleagues
• Ability to interact effectively with internal team members across the organization globally
• Excellent verbal and written communications and presentation skills required.

Education

• Bachelor’s degree in science or minimum of 3 years equivalent education / experience

Experience

• Minimum of 3 years working for a certification body either accredited or with ISO 17021 implemented.
• Experience of 1 year either implementing ISO 17021 or meeting requirements of ISO 17021
• Must be computer literate with strong proficiency in Microsoft Office applications.

Certifications

• Accreditation as Internal Auditor (desired)

SUPERVISORY REQUIREMENTS:

• Direct: Document Control Coordinator
• Indirect: N/A

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Office and laboratory environment

Equipment Used

• Laptop or Desk Computer

Travel Required

• Ability to travel to perform internal audits to other TUV locations as required (less than 10%).

Salary Range:

75,000.00 - 80,000.00 The salary range for this role takes into account the wide range of factors that are considered in making compensation decisions. It is not typical for an individual to be hired at or near the top of the range for their role.

TUV Rheinland North America EEO Statement

As a global business, TUV Rheinland North America relies on diversity of culture and thought to deliver on our goal of Creative People, Practical solutions serving our client needs, and ensures nondiscrimination in all programs and activities in accordance with Title VI and VII of the Civil rights Act of 1964. We continuously seek talented, qualified employees in our world-wide operations regardless of race, color, sex/gender, including gender identity and expression, sexual orientation, pregnancy, national origin, religion, disability, age, marital status, citizen status, protected veteran status, or any other protected classification under country or local law. TUV Rheinland North America is proud to be an Equal Employment Opportunity/ Affirmative Action Employer/ Federal Contractor desiring priority referrals of all protected veterans for job openings.

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