Quality Assurance Manager - Healthcare jobs in Georgia

JOB TITLE: Quality Manager - Analytical Instrumentation Manufacturing (On-Site)

POSITION OVERVIEW & PURPOSE:

As the Quality Manager in our analytical instrumentation manufacturing facility, you will be responsible for overseeing all aspects of quality control and assurance processes. Your primary focus will be on maintaining and improving the quality management system to ensure compliance with regulatory requirements, customer specifications, and internal standards. You will work closely with cross-functional teams to implement quality initiatives, drive continuous improvement, foster a culture of quality throughout the organization and ensure that our products consistently meet and exceed the highest standards of quality.

POSITION DUTIES & KEY RESPONSIBILITIES:

• Develop and implement quality management systems, policies, and procedures to ensure compliance with ISO standards and regulatory requirements.
• Establish and maintain quality control processes for incoming materials, in-process production, and finished products, including inspection, testing, and documentation.
• Conduct regular audits and assessments to evaluate the effectiveness of quality systems and identify areas for improvement.
• Lead investigations into quality issues, deviations, and non-conformances, and develop corrective and preventive action plans to address root causes.
• Collaborate with R&D, engineering, and production teams to ensure that quality requirements are incorporated into product design and manufacturing processes.
• Provide leadership and guidance to quality assurance personnel, including training, coaching, and performance management.
• Coordinate with suppliers and subcontractors to ensure that raw materials and components meet quality specifications and standards.
• Analyze quality data and metrics to monitor performance trends, identify opportunities for improvement, and drive corrective actions.
• Support customer inquiries, complaints, and quality-related issues, and facilitate resolution in a timely and effective manner.
• Stay current with industry trends, best practices, and regulatory changes related to analytical instrumentation manufacturing and quality management.

REQUIRED KNOWLEDGE, SKILLS & ABILITIES:

Bachelor's degree in engineering, chemistry, or a related field; advanced degree preferred. Minimum of 5 years of experience in quality management within a manufacturing environment, Certification as a Quality Manager (e.g., ASQ Certified Manager of Quality/Organizational Excellence) is a plus.

• Strong knowledge of quality management systems, standards (e.g., ISO 9001)
• Experience with quality tools and methodologies such as Six Sigma, Lean, FMEA, and statistical process control.
• Excellent analytical skills with the ability to analyze complex data sets and drive data-driven decision-making.
• Proven leadership abilities with experience in managing and developing teams.
• Effective communication skills, both verbal and written, with the ability to interact with stakeholders at all levels of the organization.
• Detail-oriented mindset with a focus on accuracy, precision, and continuous improvement.