EndereçoQuality Assurance Manager – Global Post Market Surveillance Job Description
Your Job
You’re not the person who will settle for just any role. Neither are we. Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference. Here, you’ll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands. In your role, you’ll help us deliver better care for billions of people around the world. It starts with YOU.
About Us
Huggies®. Kleenex®. Cottonelle®. Scott®. Kotex®. Poise®. Depend®. Kimberly-Clark Professional®. You already know our legendary brands—and so does the rest of the world. In fact, millions of people use Kimberly-Clark products every day. We know these amazing Kimberly-Clark products wouldn’t exist without talented professionals, like you.
At Kimberly-Clark, you’ll be part of the best team committed to driving innovation, growth and impact. We’re founded on 150 years of market leadership, and we’re always looking for new and better ways to perform – so there’s your open door of opportunity. It’s all here for you at Kimberly-Clark; you just need to log on!
Led by Purpose. Driven by You.
About You
You’re driven to perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring. You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development.
You love what you do, especially when the work you do makes a difference. At Kimberly-Clark, we’re constantly exploring new ideas on how, when, and where we can best achieve results. When you join our team, you’ll experience Flex That Works: flexible (hybrid) work arrangements that empower you to have purposeful time in the office and partner with your leader to make flexibility work for both you and the business.
Main responsibilities:
The Quality Manager will oversee global and regional post market product complaint operational activities for K-C’s reusable products. They will lead a team of post-market quality professionals providing day to day oversight and direction as they receive, assess, investigate, and facilitate timely and accurate regulatory reporting activities as applicable. This leader will ensure compliance to global regulations, K-C’s QMS, Standards and Code of Conduct. They will be responsible for preparing and presenting global and regional complaint information for activities such as routine trending, management reviews, investigations, risk assessments, and regulatory inquiries. As a subject matter expert of both the process and the complaint data, this individual will support internal audits and external inspections by regulatory bodies as directed by Management. This person will work with functional partners such as Research & Engineering, Supply Chain, Product Safety, Consumer Engagement, Medical Affairs and Regulatory for global Post Market Surveillance activities. As required, this individual will also be responsible for management of complaint process documents, CAPAs, QNCs, Deviations, and day to day complaint handling activities.
Oversee Complaint processing in compliance with KC’s Standards and applicable government regulations inclusive of 21 CFR Part 820, 803, ISO 13485:2016.
Manage personnel and associated activities of the Reusable Post-Market Surveillance Team including managing performance and developing talent.
Manage the timely in-flow of product complaints, the assignment of investigation responsibilities, and expedient processing and closure
Maintains a key role in continually examining current complaint handling processes to ensure day to day operations meet regulatory and business requirements.
Responsible for ensuring Adverse Event reporting program is being executed per procedure and regulatory requirements.
Work closely with manufacturing sites and engineering to ensure thorough and accurate investigations and drive the initiation of CAPAs when appropriate.
Identify and execute process improvement opportunities to enhance surveillance and to increase efficiency
Manage preparation and reporting of quality data for purposes of post market surveillance and as the primary input into the Management Review process
Report and discuss trends in product/process categories with Quality Assurance, Regulatory Affairs, and Research & Engineering team members/leaders.
Based on surveillance findings, collaborate with technical groups to identify product improvement opportunities; assist in establishing engineering priorities
Provide input into Health Risk/Hazard Assessments as needed in conjunction with Technical Quality
Work closely with new product introduction teams to prepare and implement tools, processes, resources, and personnel for new product launches.
Drive engagement to ensure personnel have clear expectations, appropriate tools and information, an opportunity to share, grow and develop, and are recognized for their contributions.
Highly autonomous with excellent critical thinking skills. Requires minimal management oversight. Must demonstrate situational awareness.
Manages self in accordance with the expected behaviors of the Leadership Qualities.
Effectively and consistently achieve results that meet business and individual objectives.
Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, team members, peers, and others who have a need to know. Maintain compliance to K-C Code of Conduct.
Executes/owns QNCs and CAPAs related to the complaint process; includes performing investigations, root cause analysis, developing and implementing corrective actions, completing effectiveness checks, and facilitating timely closure to all QNCs and CAPAs.
Maintain and demonstrate a high degree of knowledge and skill in quality systems, products, processes, and regulations.
Maintain compliance by completing all required training in the required timeframes.
Work on special projects as they arise.
This is a global role.
Experience and requirements:
Mandatory Qualifications
Requires a Bachelor’s degree in nursing, science, engineering or related discipline
8-10+ years broad experience in a Quality, Quality Systems Management, Quality Assurance/Control, Medical Device, Manufacturing, Research & Engineering, Consumer Service, Consumer Product Development, Regulatory function, or a closely related function.
Demonstrates appropriate knowledge of Post Market Surveillance requirements and ISO 13485 standards
Demonstrates application of LEAN methodology / Continuous Improvement skills.
Advanced command of computers and software skills.
Ability to communicate effectively with excellent oral and technical written communication skills.
Approaches problems from multiple points of view while using a variety of methodologies.
Advanced critical thinking and problem-solving skills.
High level of attention to detail.
Ability to analyze and interpret complaint and adverse event information.
Proficiency in formulating presentations and delivering to management, ensuring data provided is accurate and applicable.
Ability to work well in a team environment to accomplish goals/objectives, as well as function independently with minimal to no direction.
Demonstrated ability to successfully lead team members, direct projects and systems, and influence people at all levels of the organization.
Fluent English
Desirable Qualifications
Knowledge of Medical Device, Consumer, Cosmetic, and/or Drug regulatory requirements is desired.
Experience with or knowledge of medical terminology preferred.
Knowledge of how consumer/cosmetic products are typically used is preferred.
ASQ Certified Quality Engineer, Certified Quality Manger, or Certified Quality Auditor preferred.
Total Benefits
Here are just a few of the benefits you’d enjoy working in this role for Kimberly-Clark. For a complete overview, see
Great support for good health with medical, dental, and vision coverage options with no waiting periods or pre-existing condition restrictions. Access to an on-site fitness center, occupational health nurse, and allowances for high-quality safety equipment.
Flexible Savings and spending accounts to maximize health care options and stretch dollars when caring for yourself or dependents.
Diverse income protection insurance options to protect yourself and your family in case of illness, injury, or other unexpected events.
Additional programs and support to continue your education, adopt a child, relocate, or even find temporary childcare.
To Be Considered
Click the Apply button and complete the online application process. A member of our recruiting team will review your application and follow up if you seem like a great fit for this role.
In the meantime, check out the career’s website. You’ll want to review this and come prepared with relevant questions if and when you pass GO and begin interviews.
For Kimberly-Clark to grow and prosper, we must be an inclusive organization that applies the diverse experiences and passions of its team members to brands that make life better for people all around the world. We actively seek to build a workforce that reflects the experiences of our consumers. When you bring your original thinking to Kimberly-Clark, you fuel the continued success of our enterprise. We are a committed equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender, identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law. The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.
Additional information about the compensation and benefits for this role are available upon request. You may contact for assistance. You must include the six digit Job # with your request.
This role is available for local candidates already authorized to work in the role’s country only. Kimberly-Clark will not provide relocation support for this role.
Primary Location Brazil -Sao Paulo Additional Locations Worker Type Employee Worker Sub-Type Regular Time Type Full time
