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

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Johnson & Johnson is recruiting for a Senior Quality Assurance Analyst/ Engineer. This position will be located in Memphis, TN.

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/.

Join our team at Depuy Synthes CrossRoads as an individual contributor on the quality team You'll have the opportunity to implement processes and activities related to fulfilling QA objectives for foot and ankle products. In this role, you will be responsible for sustaining the legacy portfolio. Developing close partnerships with internal and external customers is vital to your success. We use data to identify risks and continuous improvement opportunities. This is a dynamic role with key responsibilities in sustaining quality assurance for existing product portfolio! We look forward to meeting you!

Key Responsibilities:

We are seeking a candidate that demonstrate passion, positivity, and creativity when introducing new insights. As we grow our foot and ankle portfolio, collaboration through relationship building is a key to our team's success.

• Demonstrates resilience and consistency in time management, planning, and prioritization of tasks
• Leads kaizen events to aid in collaboration with the site using 5S and lean principles
• Integrates new technology into daily workmanship
• Centralizes and creates a common single source of truth for gage management and technical inspection.
• Optimizes the receiving inspection process.
• Partners with domain experts in microbiology, validation, sterilization assurance, auditing, labelling, R& D, and packaging to ensure the quality of the product and documentation.
• Develops expertise on Quality Assurance standard methodologies and assists in the review of policies to meet the legal manufacturing objectives.
• Leads and contributes in the design of continuous improvement processes for routine data collection, analysis, and reporting.
• Innovates to identify efficiencies in the process and opportunities for digital platforms
• Develops new solutions for management of receiving inspection and quality results to partner with outside firms in developing AI tools and digital solutions
• Helps establish formal quality critical issues processes via non-conformance, SCAR, CAPA, or audit observations to surface issues of product quality, regulatory compliance, and quality systems.
• Delivers research related to regulatory changes, external trends, and strategy.
• Coaches and mentors more junior colleagues in techniques, processes, and responsibilities.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• Lead and participate in activities to determine compliance with applicable regulatory requirements and company standards.
• Develop and implement effective quality control processes and procedures to ensure product quality and reliability.
• Conduct risk assessments and develop risk mitigation strategies.
• Collaborate with teams from different departments to identify and address quality issues, and drive continuous improvement initiatives.

Qualifications

Education:

A minimum of a Bachelors or equivalent University degree is required with a focus in Engineering or science discipline preferred. Masters or Advanced degree preferred.

• Quality certifications preferred
• ASQ member.

Experience and Skills:

Required:

• Leading and co-ordination of root cause investigations and implement corrective and preventive actions to prevent quality issues from recurring.
• Certification or equivalent work experience conducting audits of quality systems and processes to ensure compliance with regulatory requirements.
• Previous history maintaining and updating quality documentation and records in accordance with company policies and regulatory requirements.
• Experience with medical device standards ISO 13485, 14971, and 10993
• Familiarity and ability to lead GRR studies and lead design transfer projects.
• Digital tool familiarity for proactive management of quality metrics. [Power BI, Tableauu, power Apps, forms]

Other:

• Proficient in English, required.
• Less than 15% travel required – domestic travel only.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]