Quality Systems Manager
Key Responsibilities
• Develop all core QMS processes, including document control, CAPA, change control, audits, and deviation management.
• Develop, implement, lead, manage and maintain the Quality Management System (QMS) to ensure compliance with regulatory standards (FDA, GMP, Food Contact Safety Regulations) and customer requirements.
• Monitor, analyze and articulate quality performance metrics, identify trends, and drive corrective and preventive actions.
• Conduct internal and supplier audits, manage non-conformance responses, and ensure timely resolution.
• Manage customer quality data, including performance metrics versus batch/formulation data, and address quality-related inquiries.
• Lead continuous improvement initiatives for manufacturing processes, ensuring efficiency and alignment with organizational goals.
• Support DFMEA/PFMEA activities with cross-functional teams, ensuring proper development and maintenance of risk assessments.
• Develop and maintain product specification management systems to meet regulatory and customer standards.
• Collaborate with leadership and cross-functional teams to identify and implement process improvements that enhance quality and productivity.
• Educate and train employees on quality processes, continuous improvement initiatives, and compliance requirements.
Requires a bachelor's degree Engineering minimum of 6 years of experience in manufacturing industry working with quality management
Successful candidates must have:
• Ability to use data to deliver corrective actions and prevent future issues; data-driven decision-making skills, leveraging root cause analysis and statistical process control to identify and solve operational challenges.
• Ability to build and manage teams of highly qualified technicians
• Perform complex tasks typically following established processes.
• Demonstrated oral and written and technical writing communication skills
• Ability to build functional collaborative relationships with internal teammates and with external customers
• Demonstrated ability to influence technical decisions
Work Authorization Requirement
This role involves access to sensitive systems, intellectual property, and strategic infrastructure, making long-term work authorization a critical requirement. As a growing company with operational limitations and a focus on protecting proprietary technologies and trade secrets, we are currently unable to sponsor employment visas for this position. Applicants must be legally authorized to work in the United States both now and for the foreseeable future (including the next five years).
Biotechnology Research
Quality Assurance
Full-time