Posted in Management about 6 hours ago.
Type: Full-Time
Location: neenah, Wisconsin
Principal Quality Specialist - Global PMS
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 Principal Quality Specialist, you will be responsible for execution of complaint handling tasks including complaint assessment, reportability determinations, complaint investigation, sample evaluations, report submissions to regulatory bodies, final complaint review, and complaint process metric reporting. Working in a team environment you will flow work as needed within the Post-Market Surveillance end to end process. You will also be a subject matter expert for the Post-Market Surveillance team overall complaint handling process, resolving complex issues throughout the lifecycle of the complaint process to ensure all aspects of the process are running smoothly, and supporting management with special projects and tasks. The Principal Quality Specialist also represents Post Market Surveillance during complaint review meetings and CAPA/QNC Review Boards as well as being responsible for conducting document control process activities for Post Market Surveillance.
In this role, you will:
Serve as the initial point of escalation for concerns from the Post-Market Surveillance Team.
Lead and serve as the subject matter expert for the complete Post Market Surveillance process, including consumer/cosmetic, drug, and medical device complaint handling and regulatory reporting, including investigation, CAPA’s, knowledge of Regulatory Requirements, and capability building and auditing of the same.
Provide oversight to team members on daily workload related to area of product/process expertise to ensure staff stay focused and productive so complaint records are managed/completed within target timeframes. This includes ensuring compliance to procedures and regulations through completion of required elements of the Post Market Surveillance process (e.g. complaint sample handling and investigation, complaint meetings, monthly reporting, etc.).
Provide input into completing complex and sensitive consumer responses.
Support internal and external audits, as needed.
Demonstrate the initiative to identify, develop, and implement/execute continuous process improvements.
Have exceptional communication skills with internal and external customers, especially during difficult situations. Conduct all communications and transactions with the utmost integrity. Communicate effectively and fully with superiors, teammates, and others who have a need to know. Maintain compliance to K-C Code of Conduct.
Provide Quality leadership or strategic support for mature platform-focused quality systems to deliver business results, routinely checking for compliance with standards/regulations, and provide training to consumers/stakeholders, as needed.
Ensure activities and items comply with both company quality assurance standards and applicable government regulations, such as GMP’s and ISO requirements.
Maintain relationships with Consumer Services, including reporting errors, troubleshooting, and coordinating complaint handling activities and improvements.
Execute/own QNCs and CAPAs related to the complaint process, including performing investigations, root cause analysis, developing and implementing corrective actions, completing effectiveness checks, and facilitating timely closure to all QNCs and CAPAs.
Maintain compliance by completing all required training in the required timeframes.
Work on special projects as needed
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:
A Bachelor’s degree in nursing, science, engineering or related discipline with 8 years or more 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.
Advanced command of computers and software skills.
Knowledge of EtQ GMPs, ISO standards, LEAN and Consumer Complaint Systems, or equivalent.
Preferred:
Knowledge of Medical Device, Consumer, Cosmetic, and/or Drug regulatory requirements.
Experience with or knowledge of medical terminology.
Knowledge of how consumer/cosmetic products are typically used.
ASQ Certified Quality Engineer, Certified Quality Manger, or Certified Quality Auditor.
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.
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.
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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