Quality Team Manager
Quality Team Manager
North Atlantic Consumer Products - Adult & Feminine Care / Neenah, WI at Kimberly-Clark
Organization Description: Adults around the globe look to Kimberly-Clark brands for discreet personal care solutions to maintain an active lifestyle. Kimberly-Clark's feminine care brands are trusted by millions of women in more than 100 countries. Our products include Depend, Poise, and Kotex.
Quality Team Manager
Requisition No. 756779
Responsible for leading a team which provides high level Quality/Regulatory support to facility, business, or staff teams and implements plans & projects that support business, team and/or organization strategy, objectives, and business results while ensuring compliance to established Quality System Management (QMS) procedures and processes
Manufacturing Operations, Corporate Quality Assurance, Regulatory Affairs, Product Safety, Research, Engineering, Packaging, Planning, Procurement, Legal, Brand/Marketing, Contract Manufacturers, Raw Material Suppliers, Vendors, Consultants, Regulatory Agencies, Third Party Registrars, Communications, Government Affairs, Consumer Services, Social Media
General Expectations and Accountabilities:
* Demonstrate safety as a value by performing all job functions safely, while also complying with corporate policies and departmental procedures, in an effort to reduce risk and eliminate loss.
* Manages self and/or team in accordance with the expected behaviors of the Leadership Qualities. Effectively achieve results that meet business and individual objectives.
* Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.
* Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed as applicable.
* Performs production and quality systems audits.
* Maintain and demonstrate a high degree of knowledge and skill in product forms, quality systems, 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.
* Executes continuous improvement activities for established processes and initiates development of new processes.
* Builds and maintains capability in Quality Management Systems (QMS), GMPs, and ISO requirements to support objectives.
Position Specific Accountabilities:
* Leads and manages the Post Market Surveillance (PMS) Team including consumer complaint handling and medical device reporting (MDR), administering performance feedback and salary handling, providing coaching and work direction to team members, recruiting and hiring new team members, and assuring all activities are prioritized and resourced appropriately.
* Responsible for continuously improving and maintaining effectiveness and compliance to IS013485, 21CFR820 & 21CFR803, Health Canada, by establishing comprehensive Post Market Surveillance, Crisis Management, and Risk Management processes and procedures, investigating non-compliances, performing root cause analysis, developing and implementing corrective actions and facilitating timely closure to all CAPAs and QNCs, and other key systems, as needed.
* Ensures PMS, Crisis Management, and Risk Management process expertise, consulting, guidance, and training to key customers (i.e. R&E, Operations Quality, Manufacturing Operations, Consumer Services, etc.) and other KCNA AFC business units. Includes business value added Quality support to business, suppliers, and other functional teams.
* Builds and maintains strong relationships across key Kimberly Clark functional areas (e.g., Consumer Services, Clinical, R&E, Regulatory, Brand/Marketing, etc.) as well as across Kimberly Clark businesses (e.g., BCC, Global Nonwovens, etc.) to foster sharing of information, swiping of best practices, and increasing KCNA AFC expertise to support overall regulatory compliance.
* Participates in, facilitates, and leads as appropriate, AFC Crisis Management/Prevention core team meetings.
* Leads and/or represents AFC PMS, Crisis Management/Prevention, and Risk Management in all enterprise related quality initiatives to ensure AFC business processes are considered and included whenever possible.
* Supports the development, implementation and communications of new concepts or initiatives to improve the way business, facilities, and support functions perform duties to achieve quality objectives.
* Provides leadership for PMS and Crisis Management/Prevention effectiveness and compliance position, processes and procedures to meet growing and rapidly changing interactive digital media including modern tools and technologies that allow for real time social media communications, interactions (blogs, microblogs, social networking sites, online communities, etc.), and escalation. Includes participating in, and leads as appropriate, AFC Crisis Management/Prevention core team meetings.
* Provides leadership for monitoring, developing and implementing Post Market Surveillance effectiveness and compliance position, processes and procedures to manage clinical/research/marketing study and survey results on medical device commercial products.
This position reports to KCNA AFC Quality Director. Has responsibility for assigned customers as well as assisting with other customers. Plans and carries out customer service and project responsibilities with minimal direction, and provides work direction to assigned team members.
* Normally requires a Bachelor's degree in a relevant discipline (e.g. Science or Engineering related) and 10+ years of broad experience in Medical Device or Consumer Product Development, Quality Engineering/Manufacturing Operations, Quality Assurance/Control, Quality System Management, or a closely related field.
* Strong verbal and technical written communication skills.
* Experience managing and coaching a high performing team.
* Prior leadership experience with large projects or systems.
* Demonstrate application of LEAN/Continuous Improvement skills.
* Working knowledge and experience with Medical Device regulatory requirements desired.
* ASQ Certified Quality Engineer, Certified Quality Manager, or Certified Quality Auditor (optional).
* Operating Budget: Indeterminate
* Personnel: work direction of 5-10 people
* Position may require travel of up to 15% to support business requirements
* Finished product facility locations: U.S., Mexico, PR China, Czech Republic
* Raw Material supplier locations: Worldwide
Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people - nearly a quarter of the world's population - trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work. If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.