Capa Manager Jobs in Bath, PA (NOW HIRING)

Description

At FMI, our purpose is to Inspire Full Potential in our team, our clients and our community. We are a leading contract manufacturer of prestige beauty, personal care, and OTC products, partnering with some of the world's most recognized brands. Our success is built on operational excellence, innovation, customer focus, and a commitment to continuous improvement.

Position Summary

FMI is seeking an experienced and results-driven Quality Manager to lead our Quality organization and ensure that customer expectations, regulatory requirements, and internal quality standards are consistently met or exceeded. This role is responsible for overseeing all aspects of the Quality Management System (QMS), including quality assurance, quality control, customer quality, compliance, audits, CAPA management, and continuous improvement initiatives.

The ideal candidate will be a hands-on leader with extensive experience in regulated manufacturing environments, a strong track record of developing high-performing teams, and a passion for driving quality excellence through scalable systems and data-driven decision making.

Key Responsibilities

• Lead and develop the Quality team, including supervisors, technicians, and quality professionals, while fostering a culture of accountability, engagement, and continuous improvement.
• Maintain and continuously improve FMI's Quality Management System to ensure compliance with FDA, cGMP, OTC, customer, and industry requirements.
• Oversee customer complaints, investigations, corrective actions, and quality communications to ensure timely and effective resolution.
• Lead internal audits, customer audits, regulatory inspections, and supplier quality activities while maintaining a state of audit readiness.
• Drive continuous improvement initiatives utilizing root cause analysis, CAPA      processes, Statistical Process Control (SPC), Lean Manufacturing, and Six      Sigma methodologies.
• Establish, monitor, and improve key quality performance indicators, including First      Time Quality, customer complaint trends, audit performance, CAPA      effectiveness, training compliance, and cost of quality.
• Partner closely with Operations, Product Development, Supply Chain, Planning, and Customer      Experience teams to ensure product quality and customer satisfaction.
• Ensure product specifications, procedures, and quality documentation are accurate, compliant, and maintained in a timely manner.
• Develop and execute employee training and development programs to strengthen technical capabilities and leadership within the Quality organization.
• Manage departmental budgets, quality-related expenditures, and initiatives focused on reducing quality costs while maintaining compliance and product excellence.
• Serve as a key contributor to operational excellence initiatives that improve efficiency, reduce waste, and enhance overall business performance.

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.

What Makes Someone Successful in This Role?

The successful candidate will be a highly analytical, customer-focused leader who is passionate about quality and continuous improvement. They will possess strong technical expertise, exceptional communication skills, and the ability to effectively lead and develop teams. They will thrive in a fast-paced manufacturing environment, utilize data to drive decisions, and consistently deliver measurable improvements in quality performance, customer satisfaction, compliance, and operational efficiency while embodying FMI's core values.

Why FMI?

At FMI, we believe our people are our greatest asset. We offer a collaborative culture, opportunities for growth, challenging work, and the ability to make a meaningful impact on the business. If you are passionate about building world-class quality systems, developing exceptional teams, and ensuring our customers receive products of the highest quality, we encourage you to apply.

Affirmative Action/EEO Statement

FMI is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based on race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or other applicable legally protected characteristics. You may view our Equal Employment Opportunity notice upon request.

FMI is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or accommodation due to a disability, you may contact us through the job portal for this job posting.

EOE, M/F/D/V.