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Quality Systems Manager

We have an opening for a Quality Systems Manager on 1st shift working out of our Mequon and Milwaukee, WI location.

The Quality Systems Manager will direct and maintain all daily operations of the Quality Assurance/Quality Control department at our Mequon and Milwaukee, WI locations. They will ensure that the sites comply with all Regulatory, Customer, and Kleen Test Products requirements as they relate to quality systems and quality of the product.

Essential Functions

  • Ensure compliance to Regulatory, Customer, and Kleen Test Products quality systems requirements.
  • Direct all activities of Laboratory Managers and Quality Department personnel.
  • Act as primary quality contact with new and existing customers to ensure products are manufactured to established standards.
  • Communicate to production management the status of the quality system as it relates to the site and all deficiencies to the systems
  • Make disposition on all raw materials, components and finished products.
  • Manage and coordinate the investigation of Out of Specification results for analytical and microbiological tests (non[1]SSR sites only).
  • Develop and maintain Master Product Records for all products manufactured at the facility.
  • Conduct routine audits of department results and records to ensure regulatory, customer, and company policies and procedures are adhered to.
  • Develop, update, and implement new and existing policies and procedures.
  • Submit all required reports in a timely manner.
  • Assume special projects under the direction of the Vice President of Quality and Director of Quality Assurance.
  • Requires a bachelor’s degree with a strong emphasis in a natural science.
  • Minimum of 5 years of Management / Supervisory experience in a regulated environment.
  • Prior experience (5 years) in Quality Assurance or Quality Control.
  • Requires the ability to read, analyze, and interpret business information, journals, technical procedures, or governmental regulations.
  • Must have excellent communication skills (written and verbal) to write reports and findings and present to all levels of management in a clear and concise manner.
  • Strong project management skills.
  • Strong mathematical concepts such as probability and statistical inference as well as the ability to apply such concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • PC proficiency to include Microsoft Office (Word, Excel, Access, PowerPoint, Sharepoint, etc.) along with Google Suite, Outlook, statistical analysis software, and contract management software.

Culture

  • Safety is KTP's top priority - everyone should go home in the same condition they came to work
  • KTP builds collaborative relationships that strengthen the overall work environment
  • Opportunity for growth, development and advancement within each department, or across departments
  • Fast-paced environment, constantly changing, and the days go by quickly!

Benefits

  • Comprehensive medical insurance plan and prescription drug coverage
  • Comprehensive dental insurance plan
  • FREE Basic Life and AD&D Insurance (company-funded & voluntary options)
  • Short and Long Term Disability coverage (FREE company-funded coverage & voluntary options)
  • Voluntary Life & Disability Program Eligibility
  • Optional Flexible Spending Accounts (medical & dependent care)
  • Prescription safety glasses cost-sharing program
  • FREE financial wellness counseling and tools
  • Time off for preventive care doctor appointments
  • 401(k) retirement plan with employer match
  • Employee Assistance Program (FREE to employees and your families)
  • Paid vacation time (earn more as your seniority grows!)
  • Company-paid holidays
  • Nicotine-cessation aid reimbursement
  • Continuing education opportunities/ Tuition Reimbursement program
  • Onsite annual Health Risk Assessments
  • Fitness membership discounts
  • Community involvement & volunteer opportunities
  • AT&T and Verizon wireless discounts

More info at - https://sites.google.com/kleentest.com/welcome/why-kt

Average salary estimate

$85000 / YEARLY (est.)
min
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$75000K
$95000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Quality Systems Manager, Kleen Test Products

Are you ready to take charge as a Quality Systems Manager at Kleen Test Products? In this dynamic role based out of our Mequon and Milwaukee, WI locations, you will be at the forefront of maintaining top-notch quality standards within our Quality Assurance/Quality Control department. You'll be leading a fantastic team, ensuring our operations align with regulatory, customer, and internal quality requirements. Your responsibilities will not only involve directing daily operations but also acting as the primary quality contact for our valued customers, ensuring we deliver products that meet established standards. You'll have the freedom to make key decisions on raw materials, manage investigations for out-of-specification results, and develop Master Product Records for all our products. You'll also conduct routine audits to ensure compliance and implement enhancements to our policies and procedures. With a focus on teamwork and a commitment to quality, you'll thrive in our fast-paced environment that offers plenty of opportunities for growth. If you have a bachelor’s degree in a natural science and a pro-level management experience of at least 5 years in a regulated environment, then this fantastic opportunity could be just what you’re looking for. Come be a part of KTP, where safety and collaboration lead the way!

Frequently Asked Questions (FAQs) for Quality Systems Manager Role at Kleen Test Products
What are the key responsibilities of a Quality Systems Manager at Kleen Test Products?

As a Quality Systems Manager at Kleen Test Products, your key responsibilities will include overseeing the daily operations of the Quality Assurance/Quality Control department, ensuring compliance with regulatory and internal quality requirements, directing the activities of Laboratory Managers, and acting as the primary quality contact with customers. You'll also manage product disposition, lead investigations into non-conformances, conduct routine audits, and develop policies to promote quality standards across all manufacturing processes.

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What qualifications do I need to become a Quality Systems Manager at Kleen Test Products?

To qualify for the Quality Systems Manager position at Kleen Test Products, you need a bachelor’s degree with a strong emphasis in a natural science. Additionally, a minimum of 5 years in management or supervisory roles within a regulated environment and at least 5 years of experience in Quality Assurance or Quality Control is required. Excellent communication skills, project management expertise, and proficiency in Microsoft Office and statistical analysis software are essential for success in this role.

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What kind of work environment can I expect as a Quality Systems Manager at Kleen Test Products?

At Kleen Test Products, the work environment is fast-paced and constantly evolving, with a strong emphasis on collaboration and safety. As a Quality Systems Manager, you'll be part of a team that values the importance of maintaining high-quality standards while fostering positive workplace relationships. You can also look forward to growth opportunities within and across departments, and a culture that encourages professional development and advancement.

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What benefits does Kleen Test Products offer to its Quality Systems Managers?

Kleen Test Products provides a comprehensive benefits package for its Quality Systems Managers, including medical and dental insurance, life insurance, short and long-term disability coverage, and a 401(k) retirement plan with an employer match. Other perks include paid vacation, continuing education opportunities, wellness programs, fitness membership discounts, and various community involvement initiatives, all designed to support employee well-being and engagement.

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How does the Quality Systems Manager role support safety at Kleen Test Products?

Safety is a top priority at Kleen Test Products, and as a Quality Systems Manager, you will play a crucial role in fostering a safe working environment. Your responsibilities include ensuring compliance with safety regulations, conducting routine audits, and promoting a culture of safety awareness among your team. By managing quality systems effectively, you contribute to the overall goal of maintaining the highest standards of safety and health for all employees.

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Common Interview Questions for Quality Systems Manager
Can you describe your experience with Quality Assurance and Quality Control?

When answering this question, you can highlight specific roles and experiences from your past that demonstrate your expertise in Quality Assurance and Quality Control. Discuss how you have managed quality systems, any relevant certifications you have obtained, and how you have systematically approached quality challenges in a regulated environment, particularly relating to industry standards.

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How do you ensure compliance with regulatory quality standards?

To effectively address this, detail your approach to establishing and maintaining quality policies and procedures in accordance with regulatory requirements. Discuss your experience conducting internal audits, conducting training, and how you keep up with changing regulations to ensure compliance and quality assurance throughout all levels of production.

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What strategies do you use to lead and motivate a quality team?

In your response, share specific leadership strategies you've used to inspire and guide your team, such as setting clear expectations, providing regular feedback, fostering a collaborative environment, and recognizing accomplishments. Emphasize your ability to communicate effectively and create a shared vision for quality excellence.

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Can you give an example of a time you handled a quality issue?

Share a real-world example where you identified a quality issue, your approach to investigating and resolving it, and how you communicated this to relevant stakeholders. Highlight what you learned from the situation and how you implemented corrective actions to prevent recurrence.

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What experience do you have with statistical analysis software?

Discuss your proficiency with specific statistical analysis software tools you have used in the past. Explain how you've leveraged these tools to assess quality data, monitor trends, and improve product quality. Emphasize your understanding of key statistical concepts used in quality control.

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How would you manage the quality system during a product recall?

Outline your crisis management skills by discussing the steps you would take in the event of a product recall. Touch on how you would coordinate with relevant departments, communicate with customers, oversee investigations, and implement corrective measures to rectify the situation and ensure compliance.

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How do you keep your team informed about changes in quality regulations?

Talk about your strategies for keeping abreast of regulatory changes and how you disseminate this information to your team effectively. You might mention regular meetings, training sessions, or using digital communication tools to ensure everyone is aware and compliant with new standards.

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What challenges have you faced in quality management and how did you overcome them?

When answering this, describe a specific challenge you encountered in quality management, the steps you took to address it, and the positive outcome. Emphasize your problem-solving skills and adaptability in overcoming obstacles.

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What is your philosophy on quality and how does it influence your work?

Share your personal philosophy on quality assurance, emphasizing how you believe it impacts not just the product but also customer satisfaction and organizational success. Discuss how this influences your daily work routines and decision-making processes.

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How do you prioritize tasks and manage projects within your quality team?

Explain your approach to project management and prioritization, potentially using specific tools or methods you find effective. Highlight how you balance urgent quality issues with long-term goals and the importance of communication and delegation within a team.

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Kleen Test Products, a subsidiary of Meridian Industries, is a privately held, family-owned company headquartered in Port Washington, Wisconsin. As a leading, full-service contract manufacturer, Kleen Test Products discreetly develops, manufacture...

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Full-time, on-site
DATE POSTED
January 5, 2025

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