Quality Systems Manager

Quality Systems Manager

Auburn, AL

Job Summary

The Quality Systems Manager is responsible for administering improvements within the Quality System to address
issues and trends effectively and in compliance with regulatory requirements and standards. The Quality Systems
Manager will lead a team of professionals to manage various aspects of the Quality System and to achieve overall
business unit metrics, provide Quality representation and support related to Quality Systems and production
changes, customer management, and equipment qualification and support.

Duties and Responsibilities

• Manage Document Control, support BHR Review, and other functions to help ensure departmental coverage
• Review document changes to ensure compliance with the Quality System; develop quality systems and
procedures as needed
• Manage Internal Audit, CAPA/Complaint, and Supplier Quality programs
• Analyze Internal Quality, CAPA/Complaint, Supplier Quality defect data to define and resolve root causes
• Prepare reports by collecting, analyzing, and summarizing data
• Ensure compliance to regulatory and customer requirements
• Oversee training program in production practices and quality assessment of goods
• Monitor, analyze and report effectiveness of quality system
• Support the implementation of continuous improvement initiatives for productive processes; participate in crossfunctional team environments to address CAPA and continuous improvement activities
• Ensure adequate corrective and preventative actions are identified and implemented
• Comply with all work rules including those pertaining to safety, health, and SiO2 QMS
• Lead a team of support personnel
• Excellent organizational skills to ensure a clean and orderly work environment
• Proficient use in Microsoft Office Suite
• Other duties as assigned

Required Skills/Abilities

• Formal training in Quality-related fields and ASQ or similar certification as Quality Technician or Quality Auditor
preferred
• Knowledgeable of FDA Quality System Regulations (21CFR Part 820) and ISO 13485 as applicable to
manufacturing environments that produce components or devices for the medical industry
• Demonstrated ability to implement and administer quality programs and interpret CAPA/Complaint data to drive
continuous improvement
• Proficient use in Microsoft Office Suite; knowledge/experience in Microsoft Visio and Project a plus
• Strong ability to change approach/method to maximize efficiency
• Strong attention to detail with good documentation practices
• Ability to follow detailed instructions quickly and effectively
• Through knowledge of Lean Six Sigma manufacturing
• Ability to adapt to frequent changes, delays, or unexpected events in the work environment
• Ability to manage competing demands
• Ability to learn new computer software and processes rapidly
• Ability to recognize and comprehend important information quickly
• Strong reasoning and judgment skills to ensure timely, sound decisions even under conditions of risk,
uncertainty, and incomplete information
• Ability to act with professionalism, integrity, and superior confidentiality
• Strong communication/interpersonal skills as well as time management skills
• Ability to include appropriate people in decision-making process
• Ability to work independently as well as with a team
• Strong team building skills; promoting a positive team spirit, exhibiting objectivity and openness to views and
opinions of coworkers
• Ability to assess own strengths/opportunities; pursues training and development opportunities, striving to
continuously build knowledge and skills

Education and Experience

• Typically, Technical degree plus two (2) years’ experience in manufacturing, management, and/or an ISO quality
systems role
• High School diploma or equivalent requires four (4) years’ experience in manufacturing, management, and/or an
ISO quality systems role

Physical Requirements

• Prolonged periods of sitting/standing
• Standard forty (40) hour work week with additional time as needed to meet company objectives
• Ability to access and navigate each department at the organization’s buildings to include walking to and from
offices/building sites, and climbing/descending stairs
• Ability to hear and react to audible alarms from distances up to 150 feet
• May involve repetitive motion