Job Description

The Quality Assurance Manager is responsible for developing, implementing, and maintaining quality management systems and compliance programs that ensure organizational adherence to regulatory requirements, industry standards, customer expectations, and company policies. This role leads continuous improvement initiatives, oversees audits and inspections, manages corrective and preventive actions, and promotes a culture of quality and compliance throughout the organization.

Essential Duties and Responsibilities

Working Conditions and Travel Requirements

•This position offers remote work flexibility, with the ability to work remotely on a regular basis while maintaining availability for on-site meetings, audits, inspections, training sessions, and business needs as required.

•Candidates must have the ability to effectively manage responsibilities in a remote environment while maintaining collaboration with cross-functional teams.

•Travel may be required based on business needs, including visits to operational sites, customer locations, regulatory agencies, vendor facilities, audits, inspections, training events, and company meetings.

•Travel frequency will vary depending on organizational priorities and compliance requirements and may range from occasional to moderate throughout the year.

•Must possess a valid driver's license and be able to travel by automobile and commercial air transportation when required.

Quality Management

•Effectively lead, influence, and manage quality and compliance initiatives in both remote and on-site environments.

•Develop, implement, and maintain quality assurance policies, procedures, and standards.

•Monitor and evaluate operational processes to ensure consistent quality performance.

•Establish key quality metrics and reporting mechanisms.

•Lead root cause analysis investigations and implement corrective and preventive actions (CAPA).

•Drive continuous improvement initiatives to enhance product, service, and process quality.

•Review and approve quality documentation, specifications, and records.

Audits and Inspections

•Plan, coordinate, and conduct internal quality and compliance audits.

•Prepare for and support external audits, customer audits, and regulatory inspections.

•Track audit findings and ensure timely resolution of corrective actions.

•Maintain audit records and documentation in accordance with established requirements.

Training and Development

•Develop and deliver quality and compliance training programs.

•Educate employees on regulatory requirements, quality standards, and company policies.

•Foster a culture of accountability, quality, and continuous improvement.

Reporting and Documentation

•Prepare regular reports on quality performance, compliance status, audit results, and improvement initiatives.

•Maintain accurate and complete records required by regulatory agencies and company policies.

•Present findings and recommendations to senior management.

Leadership

•Lead and mentor Service team members while working with PTA location managers

•Collaborate cross-functionally with Operations, Sales (Commercial), Legal, and other departments as required.

•Support strategic initiatives related to organizational excellence and risk management.

Qualifications

Experience

•10+ years of experience in quality assurance, compliance, auditing, or operational excellence.

•Experience managing regulatory compliance programs and audit activities.

Knowledge, Skills, and Abilities

•Strong understanding of quality management principles and compliance frameworks.

•Knowledge of applicable regulatory requirements and industry standards.

•Excellent analytical and problem-solving skills.

•Strong organizational and project management abilities.

•Exceptional communication and presentation skills.

•Ability to influence and collaborate across all levels of the organization.

•Proficiency with Microsoft Office Suite and quality/compliance management systems.

Working Conditions

•Office and operational environment.

•Periodic travel may be required for inspections, investigations, and training activities.

•Ability to manage multiple priorities and meet critical deadlines.

Core Competencies

•Integrity and ethical decision-making

•Strategic thinking

•Leadership and team development

•Risk assessment and mitigation

•Communication and relationship management