Quality Assurance & Compliance Manager - ISO 9001/13485

AFC Industries, Inc.; Berwick (Columbia County); Sur place; USD 85 000 - 125 000; Plein temps

Résumé du poste

AFC Industries, Inc. is seeking a Quality Assurance Manager to oversee day-to-day QA/QC activities in our manufacturing operations.

You will ensure processes comply with ISO 9001 and ISO 13485, coordinate with Engineering and Manufacturing, and drive continuous improvement in product quality. The role requires strong problem-solving, effective communication with suppliers and internal teams, and a proven track record of implementing quality systems.

Qualifications

• Working knowledge of ISO 9001/ ISO 13485 certifications is a must.
• Experience with Industrial and Manufacturing environment.
• Exceptional communication skills when dealing with suppliers, customers and internal groups.
• Prior knowledge of Quality Management software such as Uni-point or other.
• Proficiency in Microsoft Office required.
• Strong analytical and problem-solving skills.
• Minimum of 3 years' experience in quality assurance and control in a manufacturing environment.

Responsabilités

• Research regulatory and statutory compliance requirements and prepare required documentation.
• Assist with ISO 9001/ ISO 13485 Certification implementation with consultants.
• Collaborate with Engineering for Product Registration.
• Interface with Engineering and Manufacturing to ensure products can be supported without sacrificing Quality.
• Ensure design and manufacturing activities align with ISO 9001 and ISO 13485 standards.
• Coordinate verification, validation, audits, and corrective action communications.
• Maintain and update quality systems and procedures.
• Coach employees through quality initiatives.
• Reinforce quality practices throughout the organization.
• Provide regular reporting on activities and accomplishments.
• Conduct root cause analysis and implement preventive and corrective actions.
• Continue to improve the company's quality system.
• Set up, schedule and perform quality checks from manufacturing to finished product assembly.
• Support auditors to ensure compliance of products and processes.
• Develop and refine quality documentation (manuals, SOPs, etc.).

Connaissances

ISO 9001 / ISO 13485

Manufacturing environment

Communication skills

Analytical / problem solving

QA experience 3+ years

Outils

Uni-point

Microsoft Office

Description du poste

AFC Industries, Inc. is seeking a Quality Assurance Manager to oversee day-to-day QA/QC activities in our manufacturing operations.

You will ensure processes comply with ISO 9001 and ISO 13485, coordinate with Engineering and Manufacturing, and drive continuous improvement in product quality. The role requires strong problem-solving, effective communication with suppliers and internal teams, and a proven track record of implementing quality systems.