Quality Manager - Warren, OH

Reposted 10 Days Ago
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Plano, KY
In-Office
128K-158K Annually
Senior level
Healthtech • Retail
The Role
The Plant Quality Manager ensures compliance with FDA regulations, manages the quality team, develops quality plans, and drives a culture of quality in manufacturing.
Summary Generated by Built In
Quality Manager - Warren, OH

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.

The Plant Quality Manager is a key leadership position within a manufacturing facility with accountability to establish and maintain a robust Quality Management System (QMS) complaint with FDA Class 1 Medical Device and Consumer Product requirements and consistently capable of shipping product conforming to the Finished Product Specification (FPS) and other regulatory and customer requirements.

This role 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, leadership skills in building quality talent throughout a manufacturing facility and have a strong track record of meeting business objectives as a key business partner. 

This position reports to the Senior Quality Manager (staff) with a dotted line to the Warren Plant Manager.  This position will manage a total staff of approximately 2-4 salary and 8-12 hourly employees.

In this role, you will:

  • Develop and deploy the facility quality plan ensuring alignment with the K-C North America Quality Objectives and Supply Chain Strategic Business Plan.
  • Ensure adequate resources are available and trained to implement the facility quality plan and required day-to-day activities.
  • Engage with and influence the facility management team and other stakeholders such as product development, logistics and suppliers to maintain a focused quality culture within the facility.
  • Provide mentorship and direction for quality professionals plant-wide.  This includes, but is not limited to, providing strategic guidance and coaching to the system skill roles responsible for supporting plant quality systems and standards.
  • Manage yourself, your team and your interactions with others in accordance with the principles and tenets of the plant’s High Performance Work System and expected K-C Values: We Care, We Own, We Act and Ways of Working: Focus on Consumers, Play to Win, Move Fast and Grow our People
  • Establish and maintain the facility QMS, ensuring it is capable of consistently meeting FDA Medical Device requirements for Class 1 products and other customer requirements.
  • Serves as the Quality Management Representative for 3rd party, regulatory and K-C global audits.
  • Lead the Quality Management Review process for the facility and responsible for ensuring actions are assigned and complete.
  • Lead the CAPA/ QNC review board for the facility ensuring all employees associated with CAPA/ QNC action items have the capabilities and resources to complete their assignments in a timely manner.
  • Ensure incoming materials meet raw material specifications with the authority to reject nonconforming raw materials. Communicate material issues and partners with suppliers to improve performance through the SCAR (Supplier Corrective Action Request) process as appropriate.
  • Ensure finished product shipped from the facility conforms to the Finished Product Specification (FPS) and is documented in a device history record where applicable. Has authority to hold nonconforming or potentially nonconforming product. Accountable to manage nonconforming product through the nonconforming material escalation procedures.
  • Ensure the on-line asset test equipment and product test laboratory equipment is calibrated and all personnel performing product testing or inspections are qualified.
  • Ensure internal audit plans are developed and deployed and builds capability for lead auditors across the site to conduct internal audits.
  • Ensure that processes are delivering on their intended outputs by selection and review of critical quality KPIs and run to target methodologies.

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:

  • Position typically requires a minimum of a bachelor’s degree in a relevant scientific or engineering discipline and typically 7+ years’ experience in targeted area. 
  • Extensive experience in a manufacturing environment and relevant Quality roles.
  • Demonstrated people leader experience including career development and succession planning.
  • Working knowledge and experience with products requiring compliance to FDA medical device and Consumer Products Safety Commission (CPSC) regulations is a plus.
  • Experience as a Quality Management Representative in 3rd party and/ or regulatory agency audits is a plus.

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 other K-C site locations.
  • This role is located at the Warren Facility in Warren, OH 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).

US Grade 8

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.

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. 

#LI-Onsite

 Salary Range: 127,600 – 157,600 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.

Primary LocationWarren Plant

Additional Locations

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Top Skills

Consumer Product Safety Commission Regulations
Fda Compliance
Fda Medical Device Regulations
Quality Management System
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The Company
Irving, TX
31,171 Employees

What We Do

Kimberly-Clark makes the essentials for a better life with well-known brands that matter every day – at home, school, work and on the go.

Throughout our 148 years, we have challenged conventional wisdom to innovate products that better meet the needs of consumers. We have created new categories with top brands like Kleenex®, and redefined categories with Huggies® and U by Kotex®.

While growing our $18+ billion global business, we help build careers through collaborative teams that push boundaries and endless opportunities to work with some of the world’s most recognized brands. Our 43,000 employees are changing the world for the better, too, generously giving back to communities and causes around the globe.

If innovative thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.

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