Quality Manager

Quality Manager Neenah, WI Cold Springs Facility 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 Quality role, you’ll help us deliver better care for billions of people around the world.
It starts with YOU.
Summary of Position: The Quality Manager is a key role within a manufacturing facility with accountability to establish and maintain a robust Quality Management System (QMS) compliant with FDA Class 1 and Class 1 Exempt Medical Device requirements and consistently capable of shipping product conforming to the Finished Product Specification (FPS) and other regulatory and customer requirements.
This position is key in building talent and quality system capabilities throughout the manufacturing facility aligned with K-C core values of putting quality into everything we do.
The plant Quality Manager drives the culture of quality across the entire site in alignment with the strategic quality plan and supporting the business objectives.
The incumbent should have a strong background in managing Medical Device Quality Management Systems, significant skills in building.
quality talent throughout a manufacturing facility and a strong track record of meeting business targets as a key business partner.
This position reports to the Adult & Feminine Care Senior Quality Manager (staff) with a dotted line to the Plant Quality Manager.
This position will manage a total staff of 5 -10 salary employees.
Essential Accountabilities: Develops and deploys the facility quality plan ensuring alignment with the K-C North America Strategic Quality Plan and Supply Chain Strategic Business Plan.
Ensures adequate resources are available and trained to implement the facility quality plan and required day-to-day activities.
Engages with and influences the facility management team and other stakeholders such as product development, logistics and suppliers to maintain a focused quality culture within the facility.
Establishes and maintains the facility QMS, ensuring it is capable of consistently meeting FDA Medical Device requirements for Class 1 and Class 1 Exempt products and other customer requirements.
Serves as the Quality Management Representative for 3rd party and regulatory audits.
Oversees the Quality Management Review process for the facility and is responsible for ensuring actions are assigned and complete.
Manages the CAPA review board for the facility ensuring all employees associated with CAPA action items have the capabilities and resources to complete their assignments.
Ensures incoming materials meet raw material specifications with the authority to reject nonconforming raw materials.
Communicates material issues and partners with suppliers to improve performance through the SCAR (Supplier Corrective Action Request) process as appropriate.
Ensures the facility process validation system is executed appropriately and maintains compliance to medical device expectations and master validation plans.
Ensures finished product shipped from the facility conforms to the Finished Product Specification (FPS) and is documented in a device history record.
Has authority to hold non-conforming or potentially non-conforming product.
Accountable to manage nonconforming product through the nonconforming material escalation procedures.
Ensures the on-line asset test equipment and product test laboratory equipment is calibrated and all personnel performing product testing or inspection are qualified.
Ensures internal audit plans are developed and deployed and builds capability for lead auditors across the site to conduct internal audits.
Ensures that processes are delivering on their intended outputs by selection and review of critical quality KPIs and run to target methodologies.
Basic Qualifications: Position requires a minimum of a bachelor’s degree in a relevant scientific discipline and 7+ years of experience in targeted area.
Extensive experience in a Manufacturing and relevant Quality role.
Demonstrated people management experience and career development.
Working knowledge and experience with products requiring compliance to FDA medical device regulations.
Experience as a Quality Management Representative in 3rd party and/ or Regulatory audits.
Preferred Qualifications: A recognized quality management qualification is desirable such as ASQ Certified Quality Engineer / Manager of Quality Organizational Excellence / Auditor.
Working Conditions: Travel up to 10% of the work time primarily to Neenah staff site locations.
This role is located at the Neenah Cold Spring Facility in Neenah, WI which is a manufacturing facility with a mix of an office environment and manufacturing floor.
Proper personal protective equipment (PPE) must be worn at all times.
(may include safety shoes, safety glasses, ear protection, hair nets, bump caps, and beard bags).
Here are a few of the benefits you’d enjoy.
For a complete overview, see www.
mykcbenefits.
com.
Great support for good health with medical, dental, and vision coverage options.
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, including assistance to obtain proper work authorization.
The benefits provided will be per the terms of Kimberly-Clark’s applicable mobility policies.
The benefits/policy provided will decided in Kimberly-Clark’s sole discretion.