Quality Analyst

Quality Analyst - Global Post Market Surveillance and Complaint Handling

**SUMMARY OF POSITION**:
This position is a Quality professional who makes an impact and is part of a team building for the future. K-C is taking our Quality Management System and practices to the next level through a transformational journey within our Quality, Regulatory Affairs and Product Safety organizations. Individuals in this role are passionate individuals that support best in class systems and performance, who Lead the World in Essentials for a Better Life in both our Medical Device and Consumer Product Goods businesses.

This position is an entry level role that has responsibility for execution of complaint handling tasks including complaint assessment, reportability determination, complaint investigation, and final complaint review. Plans and carries out routine workload and small system improvement projects with mínimal direction; asks for assistance/guidance when appropriate. This position reports to Sr. Quality Manager - Global Post-Market Surveillance.

**ESSENTIAL ACCOUNTABILITIES**:

- Execute assigned Post-Market Surveillance activities including Complaint Assessment, Complaint Investigation/Sample Evaluation, Reportability Determination, and Final Complaint Review primarily for low severity complaints. Flow to Work to assist other team members as needed.
- Responsible for providing Post-Market Surveillance support for assigned mills/products. Responsible for completing Level 1 & 2 Complaint Investigations on behalf of mills, as needed.
- Executes continuous improvement plans and activities for established processes as assigned and supports development of new processes to deliver business results.
- Maintains relationships with Consumer Services, including reporting of and troubleshooting errors, and coordinating complaint handling activities and improvements.
- Builds and maintains capability for compliance with QMS, ISO, and FDA GMP's to support objectives.
- Ensures activities and items are compliant with both company quality assurance standards and applicable government regulations, such as FDA 21CFR820-198, Canadian Medical Device Regulations SOR/98-282, and ISO requirements.
- Maintain and demonstrate an appropriate level of knowledge and skill in quality systems, products, processes, and regulations.
- Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership.
- Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, teammates, and others who have a need to know. Maintain compliance to K-C Code of Conduct.
- Responsible for escalation of issues as they occur.
- Assists with Quality Checks as needed/assigned.
- Other tasks and special projects as assigned by management.
- Maintain compliance by completing all required training in the required timeframes.
- The primary customer base for this position is internal customers; however, the work done for the role impacts external customers as well.
- ** This is a global role.**

**WORKING CONDITIONS**:

- Travel up to 5% of the work time. Travel may also include business travels via aircrafts and motor vehicles to various locations.
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.

**Qualifications**
- Requires a Bachelor’s degree in science, engineering or related discipline
- Broad experience in a Quality, Manufacturing, Research & Engineering, or Regulatory function.
- Experience in customer service / complaint handling experience preferred.
- Basic computer and software skills.
- Good interpersonal skills.
- Attention to detail.
- Good oral and written communication skills.
- Fluent English

**Global VISA and Relocation Specifications**:
**Primary Location**

Brazil -Sao Paulo

**Additional Locations**

**Worker Type**

Employee

**Worker Sub-Type**

Regular

**Time Type**

Full time