QUALITY MANAGER
On-siteAllentown, Pennsylvania, United States
Allentown, Pennsylvania, United StatesOn-siteFull TimeBachelors DegreeSmall
Full TimeBachelors DegreeSmall
Job Summary
Quality Manager to lead FMI’s quality organization in a regulated manufacturing environment, overseeing the Quality Management System (QMS), customer quality, audits, CAPA, and continuous improvement initiatives. The role includes leading a quality team of supervisors, technicians, and professionals; ensuring compliance with FDA, cGMP, OTC, and industry requirements; driving data-driven quality improvements using SPC, Lean, and Six Sigma; managing CAPA and audits; and partnering with Operations, Product Development, Supply Chain, Planning, and Customer Experience to uphold product quality and customer satisfaction.
Required Qualifications
- Bachelor’s degree in science, Engineering, Microbiology, Chemistry or related field required
- Minimum of 8 years of progressive quality leadership experience within a manufacturing environment
- Proven experience successfully managing a Quality team of at least 8 employees
- Demonstrated success implementing measurable quality improvements and cost-saving initiatives
- Demonstrated track record of increasing responsibility and measurable business impact
- Experience within the cosmetics, personal care, fragrance, pharmaceutical, or OTC manufacturing industry preferred
- Strong knowledge of FDA regulations, cGMP requirements, quality systems, audits, CAPA processes, and compliance programs
- Experience with ERP systems and quality-related data analysis
- Intermediate proficiency with Microsoft Office Suite, including Excel, Word, and Outlook
- Strong analytical, problem-solving, and decision-making capabilities
- Experience utilizing Statistical Process Control (SPC) and data-driven quality methodologies
- Lean Manufacturing and/or Six Sigma certification
- ASQ certifications or other quality-related professional certifications
- Evidence of continuous learning and professional development
Desired Qualifications
- Bachelor’s degree in science, Engineering, Microbiology, Chemistry or related field
- Minimum of 8 years of progressive quality leadership experience within a manufacturing environment
- Proven experience successfully managing a Quality team of at least 8 employees
- Demonstrated success implementing measurable quality improvements and cost-saving initiatives
- Demonstrated track record of increasing responsibility and measurable business impact
- Experience within the cosmetics, personal care, fragrance, pharmaceutical, or OTC manufacturing industry preferred
- Strong knowledge of FDA regulations, cGMP requirements, quality systems, audits, CAPA processes, and compliance programs
- Experience with ERP systems and quality-related data analysis
- Intermediate proficiency with Microsoft Office Suite, including Excel, Word, and Outlook
- Strong analytical, problem-solving, and decision-making capabilities
- Experience utilizing Statistical Process Control (SPC) and data-driven quality methodologies
- Lean Manufacturing and/or Six Sigma certification
- ASQ certifications or other quality-related professional certifications
- Evidence of continuous learning and professional development
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