Process Quality Leader

6045-Ethicon Inc. Legal Entity

United States

On-site

USD 110,000 - 170,000

Full time

4 days ago

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Job summary

Johnson & Johnson seeks a Process Quality Leader to provide quality and technical leadership for manufacturing operations. You will identify non-conformances, investigate CAPAs, and drive continuous improvement with Manufacturing, Engineering, and Quality teams.

You will lead cross-functional quality initiatives, develop teams, and ensure compliance with QSR, GMP, ISO standards, and internal requirements while coaching supervisors and aligning with business goals.

Qualifications

Bachelor's degree in Engineering, Life Sciences, or a related technical field.
Experience in a regulated manufacturing environment (medical device preferred).
Strong knowledge of FDA 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.
Lean Six Sigma certification or equivalent continuous improvement experience.

Responsibilities

Lead investigations of non-conformances, process failures, complaints, and quality trends.
Drive root cause analysis and CAPA implementation.
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 improvement.
Partner with Manufacturing and Engineering to improve process capability and product quality.
Lead continuous improvement initiatives using Lean, Six Sigma, and statistical analysis.
Develop and maintain procedures, protocols, and training materials.

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

Education

Bachelor's degree in Engineering, Life Sciences, or related technical field

Preferred Master's degree in Engineering, Science, or related field

Tools

Microsoft Office

Data analysis tools

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

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.

Key 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.
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.
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.

Qualifications

Education

A minimum of a bachelor’s degree and/or University degree in Engineering, Life Sciences, or a related technical field required

Experience and Skills 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.
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.

Preferred

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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills