Quality Assurance Manager

Job Summary:
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.
• 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.

Job Type: Full-time

Pay: $35,000.00 - $90,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Quality Assurance: 1 year (Preferred)
• ISO 9001: 1 year (Preferred)

Ability to Relocate:

• Berwick, PA 18603: Relocate before starting work (Required)

Work Location: In person