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.
The Post Market Quality Senior Manager will oversee operational activities related to the global post market product complaint handling process. The Senior Manager will lead the team of post-market quality professionals providing day to day oversight and direction to individuals who receive, assess, investigate, and facilitate timely and accurate regulatory reporting activities as applicable. They will follow established global regulations for complaint handling and prepare and assemble complaint information for regulatory inquiries and management review. This person will provide support during 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.
In this role, you will:
Oversee Complaint processing in compliance with applicable regulations and standards such as FDA Quality System Regulation, 21 CFR Part 820, 803, ISO 13485:2016.Manage personnel and all associated activities of the Post-Market Surveillance Team including managing performance and developing talent.Manage the timely in-flow of customer 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 oversight of Adverse Event reporting program to ensure compliance.Work closely with manufacturing sites and engineering to ensure thorough and accurate investigations and drive the initiation of 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 to increase efficiency.Develop and maintain Complaint processing.Manage preparation and reporting of quality data for purposes of post market surveillance and as the primary input into the Management Review process.Based on surveillance findings, collaborate with technical groups to identify product improvement opportunities; 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 personnel have clear expectations, appropriate tools and information, an opportunity to share, grow and develop, and are recognized for their contributions.The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.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. 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.
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:
Bachelor’s engineering, science, or clinical degree plus a minimum of 10 years of related experience in the medical device field or another regulated industry.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.A recognized quality or clinical professional certification such as ASQ Certified Quality Engineer is desirable.Proven ability to communicate, influence without authority and establish effective networks across diverse teams at all levels of the organization.Proven leadership in Post-Market Surveillance including across global business units ensuring effectiveness and efficiency while maintaining compliance to global regulations. Strong leadership capabilities - able to manage a team handling high volumes of complaints, able to effectively manage cross-functional relationships and establish clear roles and responsibilities.Data analytics and statistical trending skills.Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management.Cross functional team experience and people management.Communication 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.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.US Grade 07
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.
Veterans and members of the Reserve and Guard are highly encouraged to apply.
Salary Range: $158,000– $195,000 USD
At Kimberly-Clark, pay is just one aspect of our total rewards package, which also includes a variety of benefits and opportunities to achieve, thrive and grow. Along with base pay, this position offers eligibility for a target bonus and a comprehensive benefits suite, including our 401(k) and Profit-Sharing plan. The anticipated base pay range for this role is provided above for a fully qualified hire. Actual pay will depend on several factors, such as location, role, skills, performance, and experience. Please note that the stated pay range applies to US locations only.
Veterans and members of the Reserve and Guard are highly encouraged to apply.
Kimberly-Clark will support in-country relocation for the chosen candidate for the role. The benefits provided will be per the terms of Kimberly-Clark’s applicable mobility policies. The benefits/policy provided will be decided at Kimberly-Clark’s sole discretion.
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Primary LocationNeenah - West R&E OfficeAdditional LocationsUSA-GA-Atlanta-Roswell, USA-IL-ChicagoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time