Quality Director Medical Device Jobs in Appleton, WI

Quality ManagerJob Description

You were made to create Better Care for a Better World: exploring uncharted questions, engineering innovative solutions, advancing scientific understanding, and constantly pushing the boundaries of what's possible. You want to be part ofa performance culture dedicated to solving real-world problems with purpose and precision. You want to work in an environment that promotes sustainability, inclusion, wellbeing, and career development. In this role, you'll help us shape the future and improve lives for billions of people around the world. It starts with YOU.

The Quality Manager is a key leadership position 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 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.

This position provides direct leadership to a team of six quality professionals, with responsibility for developing talent, building organizational capability, and driving continuous improvement across quality systems and processes. The role reports through the manufacturing quality organization and maintains a strong dotted-line relationship with the Plant Manager to ensure alignment between quality objectives, operational priorities, and site business goals.

In this role, you will:

• 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; 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.
• 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.
• Leads the Quality Management Review process for the facility and responsible for ensuring actions are assigned and complete.
• Leads 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. Communicate 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 non-conforming 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.

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.

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 degree in relevant scientific discipline and typically 7+ years of experience in targeted area. Extensive experience in Manufacturing and relevant Quality role required.
• Demonstrated people management experience.
• 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; 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.
• Travel up to 10% of the work time primarily to Neenah staff site locations.
• A recognized quality management qualification is desirable such as ASQ Certified Quality Engineer / Manager of Quality Organizational Excellence / 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.

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 in Kimberly-Clark's sole discretion

US Grade 08 and / or compensation may vary based on location/country

Salary Range: 127,600 - 157,600 USDAt 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 LocationNeenah - Cold Spring FacilityAdditional LocationsWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time