Quality Compliance Specialist II

The Quality Compliance Specialist II is responsible for overseeing compliance with regulatory requirements, internal quality systems, and customer standards. This role plays a key part in maintaining the integrity of the quality management system, leading audit activities, and driving corrective and preventive actions to ensure ongoing compliance and operational excellence.

Essential Job Functions:

• Manage and maintain compliance with regulatory standards, customer requirements, and internal quality systems.
• Lead internal audits and support external regulatory and customer audits.
• Develop and maintain quality policies, procedures, and compliance documentation.
• Lead investigations into compliance issues and oversee corrective and preventive action implementation.
• Monitor quality system performance and identify opportunities for improvement.
• Provide training and guidance to teams on quality and compliance requirements.
• Collaborate with leadership to ensure processes align with regulatory and industry standards.
• Participate in cross-functional improvement initiatives.
• Assist with supplier quality and compliance programs.
• Support organizational training initiatives related to quality and compliance.

Schedule:

The standard schedule is Monday through Friday, 8-10 hour shifts, with the flexibility to work evenings and weekends as needed based on workload demands.

Note:  The duties and responsibilities described on this document are not necessarily a comprehensive list and additional tasks may be assigned to the employee from time to time; and the scope of the job may change as necessitated by business demands.

Required Qualifications:

• Bachelor’s degree in Quality, Engineering, Business, or related field preferred.
• 4–8 years of experience in quality assurance, compliance, or regulated manufacturing environments.
• Experience managing audits and regulatory inspections.
• Strong knowledge of quality management systems and compliance frameworks.
• Excellent analytical, documentation, and communication skills.
• Must be a U.S citizen.

Physical Requirements:

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 50 pounds at times.

Working Conditions

• Onsite position with office environment and exposure to manufacturing areas.
• Flexibility to adapt to peak workloads and tight deadlines while maintaining accuracy and efficiency.

Reasonable Accommodations

 To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.