Job Function: Supply Chain Manufacturing
Job Sub Function: Manufacturing Process Improvement
Job Category:People Leader
All Job Posting Locations:Athens, Georgia, United States of America, Cornelia, Georgia, United States of America
Job Description:Job SummaryThe Process Quality Leader (PQL) provides quality and technical leadership to support manufacturing operations and drive continuous process improvement. This role partners closely with Manufacturing, Engineering, and Quality teams to identify process failures, investigate non-conformances, implement corrective and preventive actions (CAPAs), and ensure compliance with Quality System Regulations (QSR), GMP, ISO standards, and company requirements.
The PQL leads quality improvement initiatives, analyzes performance trends, supports operational excellence efforts, and develops teams while fostering a culture of quality, compliance, and continuous improvement.
Key ResponsibilitiesQuality & Compliance Leadership- Lead investigations of non-conformances, process failures, complaints, and quality trends.
- Drive root cause analysis and implementation of effective corrective and preventive actions (CAPAs).
- Ensure compliance with QSR, GMP, ISO, and internal quality requirements.
- Support audits, inspections, and quality system assessments.
- Review quality data and trends to identify opportunities for process improvement.
Process Improvement- Partner with Manufacturing and Engineering to improve process capability, product quality, and operational efficiency.
- Lead continuous improvement initiatives using tools such as Lean, Six Sigma, FMEA, and statistical analysis.
- Develop and maintain procedures, protocols, and training materials that support process enhancements.
- Recommend improvements to manufacturing systems, equipment, and processes based on data analysis.
Leadership & Team Development- Lead and develop quality and technical professionals while supporting performance management and career development.
- Provide coaching and guidance to manufacturing supervisors and cross-functional teams.
- Drive accountability for safety, quality, delivery, and continuous improvement performance.
- Foster collaboration across Quality, Manufacturing, Engineering, Supply Chain, and other functional areas.
Leadership Expectations- Demonstrates strong people leadership and coaching capabilities.
- Builds a culture of quality, compliance, accountability, and continuous improvement.
- Influences stakeholders across multiple organizational levels.
- Drives execution while balancing business, quality, and customer needs.
- Supervises supervisors and/or larger technical teams.
- Serves as the primary quality partner to Business Unit leadership and may act on behalf of the Manufacturing or Business Unit Manager.
Business & Operational Support- Support business unit objectives related to quality, cost, productivity, and customer satisfaction.
- Participate in strategic planning and operational reviews.
- Present quality metrics, trend analyses, and investigation results to leadership teams.
- Support new product introductions, process validation activities, and equipment qualifications.
QualificationsEducation- A minimum of a bachelor's degree and/or University degree in Engineering, Life Sciences, or a related technical field required
Experience and SkillsRequired- Experience in a regulated manufacturing environment (medical device preferred).
- Strong knowledge of FDA Quality System Regulations (QSR), GMP, and ISO requirements.
- Experience with quality investigations, CAPA, root cause analysis, and process improvement methodologies.
- Strong analytical, communication, and problem-solving skills.
- Proficiency with Microsoft Office and data analysis tools.
Preferred- Master's degree in Engineering, Science, or related field.
- Lean Six Sigma certification or equivalent continuous improvement experience.
- Experience leading cross-functional teams and driving organizational change.
- Experience supporting audits, regulatory inspections, and validation activities.
Other:- May require up to 10% domestic and/or international travel to other locations and sites
Required Skills: Preferred Skills:Agile Manufacturing, Chemistry, Manufacturing, and Control (CMC), Coaching, Controls Compliance, Data Gathering and Analysis, Detail-Oriented, Developing Others, Document Management, Financial Competence, Goal Attainment, Good Manufacturing Practices (GMP), Inclusive Leadership, Leadership, Operational Excellence, Plant Operations, Process Control, Quality Management Systems (QMS), Quality Standards, Quality Systems Documentation, Time Management
