Sr Quality Manager - Global Post Market Surveillance and Complaint Handling - Kimberly-Clark Corporation
Madison, WI 53701
About the Job
Job Description
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 this role, you’ll help us deliver better care for billions of people around the world. It starts with YOU.
As the Post Market Sr. Quality Manager, you will oversee the operational activities related to the global post market product complaint handling process. This includes leading a team of post-market quality professionals who receive, assess, investigate, and facilitate timely and accurate regulatory reporting activities in compliance with established global regulations for complaint handling. You will also prepare and assemble complaint information for regulatory inquiries and management review and provide support during inspections by regulatory bodies as directed by Management and work closely with functional partners such as Research & Engineering, Supply Chain, Product Safety, Consumer Engagement, Medical Affairs and Regulatory for global Post Market Surveillance activities.
In this role, you will:
Oversee complaint processing to ensure compliance with applicable regulations and standards such as FDA Quality System Regulation, 21 CFR Part 820, 803, ISO 13485:2016.
Manage personnel and associated activities of the Post-Market Surveillance Team, including performance management and talent development.
Ensure timely processing of customer complaints, assign investigation responsibilities, and expedite processing and closure.
Continually examine current complaint handling processes to ensure they meet regulatory and business requirements.
Oversee the Adverse Event reporting program to ensure compliance.
Collaborate with manufacturing sites and engineering to ensure thorough and accurate investigations and initiate CAPAs when appropriate.
Define reports, monitor and prevent delinquency or backlog in all aspects of the surveillance process.
Identify process improvement opportunities to enhance surveillance and increase efficiency.
Develop and maintain complaint processing.
Manage preparation and reporting of quality data for post market surveillance and as the primary input into the Management Review process.
Collaborate with technical groups to identify product improvement opportunities based on surveillance findings and assist in establishing engineering priorities.
Review Health Risk/Hazard Assessments as needed in conjunction with Technical Quality.
Work closely with new product introduction teams to prepare tools, processes, resources, and personnel for new product launches.
Drive engagement to ensure teams have clear expectations, appropriate tools and information, an opportunity to share, grow and develop, and are recognized for their contributions.
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 more than 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.
Led by Purpose. Driven by You.
About You
You 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.
In one of our professional roles, you’ll focus on winning with consumers and the market, while putting safety, mutual respect, and human dignity at the center. To succeed in this role, you will need the following qualifications:
A Bachelor's degree in engineering, science, or clinical field and at least 10 years of related experience in the medical device field or another regulated industry.
Knowledge of Regulation 21 CFR Part 820, Part 803, and applicable international quality standards and regulations, including ISO 13485:2016, Canadian MDR, and EU Medical Device Regulation.
Recognized quality or clinical professional certification, such as ASQ Certified Quality Engineer.
Proven ability to communicate effectively, influence without authority, and establish effective networks across diverse teams at all levels of the organization.
Proven leadership in Post-Market Surveillance across global business units, ensuring effectiveness and efficiency while maintaining compliance with global regulations. Strong leadership capabilities, able to manage a team handling high volumes of complaints, effectively manage cross-functional relationships, and establish clear roles and responsibilities.
Possess data analytics and statistical trending skills.
Experienced in project management, including development of project plans, status meetings, project reporting, etc., and organizational change management.
Experienced in cross-functional team management and people management.
Able to communicate in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks, and communicating potential conflicts to senior leaders.
Possess ASQ certification as Certified Quality Engineer or Green Belt/Black Belt.
Expert understanding and application of appropriate global medical device regulations, requirements, and standards.
Proven experience in Risk Management processes, including cross-sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations.
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 www.mykcbenefits.com.
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, please check out the careers website.
And finally, the fine print….
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.
Employment is subject to verification of pre-screening tests, which may include drug screening, background check, and DMV check.
Total rewards at Kimberly-Clark includes pay and a full package of benefits that can be tailored to individual needs. The anticipated pay range for this job has a range of $158,000-$195,000 in addition to bonus potential. Individual pay levels will be based on multiple factors including, but are not limited to, location, role, skill set, and level of experience.
Additional information about the compensation and benefits for this role are available upon request. You may contact 866-444-4516 – when prompted for employee ID, say “OTHER CALLER” - or kcchrprod@service-now.com for assistance. You must include the six-digit Job # with your request.
Veterans and members of the Reserve and Guard are highly encouraged to apply.