Through collaboration, you can turn good ideas into great outcomes
You’re a leader who believes that it often takes a variety of viewpoints to reach more informed outcomes. You’re energized by open dialogue and collaborative brainstorming, and you bring that enthusiasm to your team. We appreciate your ability to stimulate new thinking, knowing that different perspectives can lead to exciting outcomes for all. Let’s talk about how we can work together.
PRIMARY DUTIES & RESPONSIBILITIES:
Quality Team Leader of Baby Child Care team, providing strategy, capability-building, and direct support to the facility in the areas of Quality and Regulatory Compliance.
Assures compliance to internal and external standards such as Kimberly-Clark Quality Management System (QMS) and FDA Medical Device regulatory requirements.
Identify, develop and provide leadership to implement products, processes, materials, systems and procedures to achieve business objectives.
Provide leadership to a team providing support for the visual and physical inspection, sampling, testing and control of products and materials.
Maintain and continue development of the Non-conforming product/Quality Non-conforming reporting system.
Manage the BCC customer complaint process, including initiation of 4SPS, and Batch Lot History Record investigations
Provide Quality leadership and expertise regarding raw material and finished product issues/concerns.
Has functional oversight and responsibility for quality systems executed by the Quality department, including Management Review, control of Documented Information, Supplier Quality Management, Complaint Investigation and Management, Internal Audit, Monitoring & Measurement, Analysis & Evaluation, and CAPA.
Participate in the development of others in the area of incumbent's expertise, while demonstrating an understanding of those with a diverse background or experience.
Contribute to a diverse environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results.
Execute continuous improvement activities for established processes and initiates/supports development of new processes.
We work best when we put our heads together
Teamwork often yields the most productive and even exciting results at our organization. That’s why you and the people you manage will be provided with the support and incentives to work successfully together. Your talent for leading your team to participate and creating a supportive environment where people feel free to share ideas will make you a valuable addition to our staff.
QUALIFICATIONS:
Bachelor’s degree in science, engineering or related discipline and 8+ years of broad experience in a Quality, Manufacturing, Research or Regulatory function.
Requires prior leadership experience with teams, systems, and/or large sized projects.
Knowledge of ISO9001 and FDA Medical Device regulations is strongly desired.
Desired experiences include some combination of: CAPA/Problem-solving, Change Management, Risk Management/FMEA, and application of LEAN/ Continuous Improvement skills.
Self-motivated to identify and problem-solve the issues.
Ability to interface effectively with various levels of the organization.
Incumbent must demonstrate strong organization / detail-oriented skills.