Quality Assurance/Control Manager

AFC Industries, Inc.; Berwick (Columbia County); On-site; USD 85,000 - 125,000; Full time

Job summary

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.

Responsibilities

• 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.).

Skills

ISO 9001 / ISO 13485

Manufacturing environment

Communication skills

Analytical / problem solving

QA experience 3+ years

Tools

Uni-point

Microsoft Office

Job description

Manufacturing company is seeking a Quality Assurance Manager to assist with the day-to-day functions and is responsible for managing the activities necessary to assure the quality of the process and product. Additionally, he/she will be responsible for assuring that the processes used/identified to produce and control products are within compliance to the applicable regulations. The person in this position interacts with various company departments and is responsible for creating an environment of compliance by overseeing the implementation of quality goals. In addition, the company is seeking someone who has experience with ISO 9001 and ISO 13485 experience.

Principal Duties And Responsibilities

• Research National and International regulatory and statutory compliance requirements and prepare the required documentation.
• Assist with the implementation of ISO 9001/ ISO 13485 Certification with current consultants.
• Collaborate with the Engineering department for Product Registration.
• Interface with Engineering and Manufacturing Operations to ensure product offerings can be supported without sacrificing Quality.
• Ensure that our company's design and manufacturing activities are aligned with industry standards, regulations as well as the ISO 9001 standards and ISO 13485.
• Support and coordinate verification, validation activities, process monitoring, Conduct audits, document findings and corrective action recommendations, if necessary. Communicate findings with appropriate management in a timely fashion so behaviors can be addressed and corrected.
• Maintain and update quality systems and procedures as required.
• Coach employees through all quality initiatives.
• Consistently reinforce quality practices throughout the organization.
• Provide daily/weekly/monthly reporting on activities and accomplishments.
• Conduct root cause analysis and implement preventive and corrective actions for all concerns.
• Continually improve and/or enhance company's quality system.
• Setup, Schedule and Perform quality control checks from the part manufacturing process to finished product assembly
• Support internal/external quality auditors to ensure that products and processes are in compliance.
• Assist/Develop/Refine all company quality documentation. Manuals, work instructions, standard operating procedures, quality procedures, etc.

Required Skills And Experience

• Working knowledge of **ISO 9001/ ISO 13485 certifications** is a must.
• Experience with Industrial and Manufacturing environment
• Exceptional communication skills required when dealing with suppliers, customers and internal groups and auditors.
• 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.

Preferred Skills And Experience

• **3 years ISO 13485 auditor** experience preferred.
• Experience in WMS, ERP or MRP systems a plus.
• Some travel required for supplier visits / audits.
• Experience using statistical analysis and other presentation data formats preferred.