Description:
Job Title: Quality Assurance, QA Manager
Department: Quality - Production
Reports To: Plant Manager with matrix reporting relationship with Quality Director
FLSA Status: Exempt
Travel: 25% as needed

JOB SUMMARY

The Quality Manager is responsible for managing the quality processes, people and system, Quality Management System (QMS) to ensure products being shipped meet the required standards and specifications.

Essential Duties & Responsibilities

• Oversee and manage quality control inspectors and technicians
• Develop and implement quality assurance policies and procedures
• Report product or service quality levels – Defective Parts Per Million, DPPM, for internal quality issues and for external quality issues from customers
• Conduct regular quality audits to ensure compliance with regulations and standards
• Analyze data to identify areas for improvement in the quality management system
• Collaborate with cross-functional teams to address quality issues and drive continuous improvement
• Train employees on quality standards and best practices
• Communicate quality issues along with the corrective and/or preventative measures
• Prepare and present quality reports to senior management
• Stay updated on industry trends and best practices in quality assurance
• Implement and enforce document control processes, procedures, and standards.
• Ensure compliance with regulatory and industry standards (e.g., ISO 9001, FDA regulations).
• Support audits and inspections by providing relevant documentation and reports.
• Perform root cause analysis of issues and provide feedback for process improvements.
• Review product documentation to ensure completeness, accuracy, and clarity.
• Ensure compliance with regulatory and industry standards (such as ISO, FDA, or CMMI).
• All other duties as assigned.

Requirements:

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education Requirements/Work Experience

• Bachelor’s degree in Engineering, Business, or related field from an accredited college or university or equivalent experience of 5 to 7 years in field of Quality Management positions.
• Manufacturing industry experience preferred.
• Strong knowledge of quality assurance principles and methodologies (ISO 9001 or Equivalent)
• Excellent analytical and problem-solving skills
• Effective communication and interpersonal abilities
• Attention to detail and accuracy
• Ability to lead and motivate a team
• Proficiency in quality management tools and software
• Knowledge of relevant regulations and standards in the industry

• Organize, track, and maintain all documents related to projects, products, or operations.Able to effectively manage multiple projects and/or priorities at the same time

• Computer Skills
  To perform this job successfully, an individual should be proficient with Microsoft Office - MS Word, Excel, PowerPoint and experience with Quality Management System administration.

• Oversee and manage quality control inspectors and technicians
• Develop and implement quality assurance policies and procedures
• Report product or service quality levels – Defective Parts Per Million, DPPM, for internal quality issues and for external quality issues from customers
• Conduct regular quality audits to ensure compliance with regulations and standards
• Analyze data to identify areas for improvement in the quality management system
• Collaborate with cross-functional teams to address quality issues and drive continuous improvement
• Train employees on quality standards and best practices
• Communicate quality issues along with the corrective and/or preventative measures
• Prepare and present quality reports to senior management
• Stay updated on industry trends and best practices in quality assurance
• Implement and enforce document control processes, procedures, and standards.
• Ensure compliance with regulatory and industry standards (e.g., ISO 9001, FDA regulations).
• Support audits and inspections by providing relevant documentation and reports.
• Perform root cause analysis of issues and provide feedback for process improvements.
• Review product documentation to ensure completeness, accuracy, and clarity.
• Ensure compliance with regulatory and industry standards (such as ISO, FDA, or CMMI).
• All other duties as assigned