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Job Function:

Quality

Job Sub** **Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America, Cornelia, Georgia, United States of America

Job Description:

Johnson & Johnson is recruiting for a NC CAPA Site Lead to be located on site in Cornelia or Athens, GA.

The NC/CAPA Site Lead performs quality support duties including maintenance of the Non-Conformance, Corrective Action and preventive action (CAPA) and supplier systems as well as providing support for special quality projects. He/ she ensures and maintains a state of inspection readiness and performs in various quality functional areas and maintains expertise. Furthermore he/ she will act as the CAPA and NC Site Lead and will be partnering with other manufacturing plants and key business partners.

Responsibilities:

Under the direction of the Quality Systems Manager and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

+ Assist in managing Quality Systems issues through internal audits, testing, and intermediate checks, ensuring compliance with organizational Quality Assurance standards, international standards, and government regulations.

+ Develop expertise on systems and standards to review audit results and regulatory inspection reports, supporting the development of effective corrective action plans.

+ Identify and evaluate potential impacts of risks uncovered during internal audits.

+ Design and implement processes that facilitate the effective deployment and monitoring of quality systems.

+ Implement data collection processes, utilizing dashboards and performance monitoring tools to gather internal feedback and improve quality metrics.

+ Establish collaborative relationships with internal partners and regulatory agencies to deepen subject matter expertise and ensure compliance with regulatory requirements.

+ Coach colleagues on techniques, processes, and responsibilities related to quality assurance.

+ Apply Johnson & Johnson’s Credo and Leadership Imperatives in daily interactions to foster a quality-driven culture.

+ Lead and coordinate essential Quality Systems meetings, including DRB, CAPA Review, PQM, and QSMR.

+ Provide support during audits conducted by Notified Bodies, Competent Authorities, franchises, customers, and internal teams.

+ Support, lead, and improve the Non-conformance (NC) and Corrective and Preventive Actions (CAPA) processes resulting from audits and other quality indicators.

+ Ensure compliance with applicable quality management systems, environmental, safety, and occupational health policies (e.g., ISO 13485, ISO 14001, OSHAS 18001).

+ Offer technical expertise to ensure conformance to ISO, FDA, and MDD regulations and standards.

+ Prepare for, facilitate, and participate in audits, inspections, and staff training sessions.

+ Trend data, identify issues, and recommend or implement appropriate corrective actions.

+ Assess existing quality systems and propose improvements to enhance quality, efficiency, and cycle time reduction.

+ Maintain accurate and timely quality records, including nonconformances, project outcomes, and stakeholder feedback.

+ Coordinate change control documentation and approval processes.

+ Develop proposals and support the formulation of corrective action plans, ensuring proper implementation and follow-up.

+ Lead and own CAPAs, NCs, and audit observations, ensuring timely resolution.

+ Verify closure of corrective and preventive actions, ensuring ongoing compliance.

+ Ensure investigations of non-conformances and quality system activities adhere to good manufacturing practices and regulatory requirements.

+ Develop and implement quality data reports for other plants, as needed.

+ Drive continuous improvement initiatives within the Quality System.

+ Collaborate effectively across departments and with corporate partners to maintain consistent and effective quality practices.

+ Work with cross-functional teams at other finishing sites to ensure alignment and compliance.

+ Conduct investigations, analyze trends, and report on quality-related processes.

+ Maintain a thorough understanding of process criteria, regulations, and the business impact of quality decisions.

+ Communicate business issues and opportunities to manage and proactively escalate.

+ Ensure compliance with all health, safety, and environmental policies and regulations—both personally and for subordinates, if applicable.

+ Perform additional duties as assigned to support quality and compliance initiatives.

+ Responsible for communicating business-related issues or opportunities to next management level

+ Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Qualifications:

+ University/Bachelor’s Degree is required

+ Minimum of 4 Years of Work Experience is required

+ Demonstrated knowledge and application ISO13485, Good understanding of applicable standards and regulations e.g., ISO 14971, EU MDD 93/42/EEC, EU MDR 2017/745, US FDA QSR 21 CFR Part 820, Australian TGR, Brazilian RDC 665, Japanese Ordinance No.169, Canadian MDR SOR 98-282

+ Fluency in English

+ Practical experience of Lean Manufacturing and Lean tools.

+ Effective communication skills.

+ Effective technical writing.

+ Statistical and analytical problem solving

+ Sense of urgency, intellectual curiosity, prudent risk-taking.

+ Advance computer skills and use of software applications preferred.

+ Lead auditor certification preferred.

+ Knowledge and proficiency in standard computer applications.

+ Data interpretation and analysis / graphing.

+ Ability to draw conclusions through data analysis to influence actions that improve quality and reduce risk.

+ Good verbal and written communication skills with a good team working ethos.

+ Ability to manage multiple items concurrently.

+ Strong organization skills to address hundreds of NC / CAPA items that may be active at any time.

_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._