AddressDescription
Memphis Distribution Center is recruiting for a Quality Engineer 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/.
The Quality Engineer provides technical leadership by developing, establishing, and maintaining Quality Engineering methodologies, systems, and practices. This position also drives product/process improvements with the objective of product safety and end-user satisfaction.
Are you interested in joining a team delivering outstanding results to our customers and patients? Apply now for this exciting opportunity!
Key Responsibilities:
- Collect and perform analysis of data such as NC, CAPA and Audit data for DRB and Management Review meetings.
- Applies industry and process excellence standards on a moderately complex level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
- Support material review board (MRB) with investigation and disposition of nonconforming materials.
- Consults on development of quality improvements and recommends alternatives. Guides the architecture, governance, and measurement of assigned programs. Leads the development and implementation of system level improvement plans across a variety of areas to increase efficiency, reduce cost and streamline operations.
- Work with various departments to ensure timely closure of CAPAs, NCs, Audit actions and Complaints. Document deficiencies, including root cause, corrective and preventive action plans.
- Support with equipment qualifications (IQ/OQ/PQ), process validations and process improvements.
- Lead risk analysis activities and maintaining up to date risk management documents.
- Lead and support Internal and External Audits for the site.
Qualifications
Education:
- A minimum of a University/Bachelors degree in Quality, Mechanical, Biomedical, or Process Engineering, or equivalent required.
Experience and Skills
Required:
- Must have two to four (2-4) years of related work experience in the Medical field.
- Experience in Quality Engineering.
- Strong understanding in GMP and/or regulatory requirements, specifically 21 CFR 820, ISO 13485, and ISO 14971.
- Strong communication, collaboration, and problem-solving skills.
- Both, FDA, and ISO regulations knowledge.
- Strong root cause analysis skills.
Preferred:
- Operations supplier quality experience.
- Experience in the medical device and/or pharmaceutical industry.
- FDA CFR Part 820 and/or ISO 13485 knowledge.
- Auditing background.
- Six Sigma, Lean, or ASQ Certification and training courses.
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 .
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.
