Johnson & Johnson is recruiting for a Staff Quality Engineer, located in Memphis.
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/.
Key Responsibilities:
• Lead and participate in activities to determine compliance with applicable regulatory requirements and company standards.
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• Responsible for site administrator for document control and training.
• Develop and implement effective quality control processes and procedures to ensure product quality and reliability.
• Conduct risk assessments and develop risk mitigation strategies to ensure the safety and efficacy of our medical devices.
• Collaborate with teams from different departments to identify and address quality issues, and drive continuous improvement initiatives.
• Perform root cause investigations and implement corrective and preventive actions to prevent quality issues from recurring.
• Conduct audits of quality systems and processes to ensure compliance with regulatory requirements.
• Maintain and update quality documentation and records in accordance with company policies and regulatory requirements.
• Create process efficiency and introduce digital tools for proactive management of quality metrics.
Qualifications
Education:
• Bachelor's degree or equivalent in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field.
Experience and Skills:
Required:
• Minimum seven (7) years of experience in quality engineering, preferably in quality systems for medical devices.
• Proven understanding of quality management systems, regulations, and standards (e.g., ISO 13485, FDA QSR).
• Excellent problem-solving and analytical skills.
• Outstanding attention to detail and a dedication to producing high-quality work.
• Ability to work effectively in a fast-paced and agile environment.
• Demonstrated communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.
Preferred:
• Experience with PTC Windchill PLM or equivalent system, preferred.
• Experience with ETQ or other CAPA Non-conformance tool, required.
• Experience with power BI or other digital tools offerings, a plus.
Other:
This position will be located in Memphis, TN and may require up to 10% domestic or international travel.
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.