Job Title: Quality Manager
Location: Fredonia, Wisconsin
Job Overview
We are seeking a detail-oriented and proactive Quality Manager to lead and improve the company’s quality management systems. This role will focus on ensuring compliance with regulatory standards, conducting internal and external audits, and driving continuous improvement initiatives across production and operational processes.
The ideal candidate is a critical thinker with strong analytical skills who can identify risks early, implement preventive actions, and build strong relationships with internal teams and external partners to maintain the highest quality standards.
Key Responsibilities
- Develop and implement standardized production, quality, and customer service standards across operations.
- Lead quality management system (QMS) initiatives to ensure consistent product and process quality.
- Conduct internal and external quality audits and prepare detailed audit reports with findings and corrective actions.
- Identify potential risks and quality issues through root cause analysis and preventive action strategies.
- Ensure compliance with FDA regulations, GMP standards, and company quality policies.
- Collaborate with cross-functional teams to improve processes and quality performance.
- Support continuous improvement programs and implement best practices in quality management.
- Build and lead a strong quality team through coaching, mentoring, training, and performance evaluations.
- Work with key partners and stakeholders to gather feedback and improve quality systems.
- Monitor quality metrics and drive improvements to enhance product reliability and customer satisfaction.
Required Qualifications
- Bachelor’s degree in Chemistry, Biology, Engineering, or a related field.
- Experience with quality control, auditing, and regulatory compliance.
- Strong knowledge of FDA regulations and GMP standards.
- Experience implementing and managing Quality Management Systems (QMS).
- Excellent analytical, problem-solving, and attention-to-detail skills.
- Strong communication and leadership abilities.
- Ability to manage multiple priorities and drive process improvements in a fast-paced environment
