Process Quality Leader
About The Position
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com./ Job Summary The 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.
Requirements
- A minimum of a bachelor’s degree and/or University degree in Engineering, Life Sciences, or a related technical field required
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
- 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.
- 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.
- 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.
Benefits
- Inclusive work environment
- Respect for diversity and dignity of employees
- Recognition of employee merit
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What This Job Offers
Job Type
Full-time
Career Level
Manager
