Quality Assurance Manager

Job Description

The Quality Manager is responsible for overseeing and maintaining the quality management system for the tissue manufacturing and distribution process to ensure products meet or exceed customer expectations and comply with regulatory standards. Reporting directly to the Director of Operations, the Quality Manager will lead quality assurance and control initiatives, drive continuous improvement, and foster a culture of quality throughout the organization.

Key Responsibilities

Quality Management System (QMS): Develop, implement, and maintain the QMS (QM/SOP) to ensure compliance with industry standards (FDA, AATB cGTMP or other relevant regulations) and customer requirements. Manage change control of all controlled documents.

Quality Control: Oversee inspection processes for raw materials, in-process production, and finished tissue products to ensure adherence to specifications.

Process Improvement: Collaborate with R&D, production and quality teams to identify and implement process improvements that enhance product quality and operational efficiency.

Non-Conformance Management: Investigate quality issues, conduct root cause analyses, and implement corrective and preventive actions (CAPA) to address non-conformances.

Audits and Compliance: Lead internal and external quality audits, ensuring compliance with regulatory, customer, and certification requirements.

Training and Development: Train and educate staff on quality standards, procedures, and best practices to promote a quality-focused culture. Maintain all training files.

Supplier Quality: Work with the team to evaluate and monitor supplier performance, ensuring materials meet quality standards.

Documentation and Reporting: Maintain accurate quality records, generate reports, and present key performance indicators (KPIs) to the Director of Operations and senior leadership.

Customer Engagement: Address customer complaints and feedback, collaborating with sales and customer service teams to resolve quality-related issues.

Safety and Environmental Compliance: Ensure quality processes align with workplace safety and environmental regulations.

Qualifications

Bachelor’s degree in Engineering, Quality Management, Manufacturing, or a related field.

5+ years of experience in quality management, preferably in human tissue manufacturing, or a related industry.

Strong knowledge of quality management systems, standards (e.g., ISO 9001), and regulatory requirements.

Proven experience in leading audits, root cause analysis, and CAPA processes.

Excellent analytical, problem-solving, and decision-making skills.

Strong leadership and communication skills to manage cross-functional teams and interact with stakeholders.

Proficiency in quality tools (e.g., Six Sigma, Lean, SPC) and software (e.g., ERP systems, quality management software).

Certification in quality management (e.g., ASQ Certified Quality Manager, Six Sigma Green/Black Belt, CTBS) is a plus.

Working Conditions

Primarily based in an office and manufacturing environment with exposure to production areas.

May require occasional travel to supplier sites or customer locations.

Ability to work flexible hours to support production schedules as needed.

Physical Requirements

Ability to stand, walk, and navigate facilities for extended periods.

Occasional lifting of materials or equipment up to 25 lbs.

Company Description

Applied Biologics is a fully-integrated life sciences company providing research, product development, manufacturing and distribution of medical technologies. Since 2010, Applied Biologics has been dedicated to providing innovative biologic solutions to deliver optimal patient outcomes.

Full-time