Johnson & Johnson is currently seeking a Quality Engineer to be located at San Lorenzo, PR.
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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
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We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Key Responsibilities:
- Ensures compliance of areas of responsibility with the department, company, OSHA, ISO and QSR concerning safety, good housekeeping practices and manufacturing practices.
- Supports Operations in the generation of quality indicators, evaluation and implementation of action plans to eliminate root causes of non-conformances and in the development and execution of strategic and tactical plans to run base business.
- Supports/initiates investigations of non-conformances (such as but not limited to NCR, CAPA, Audit Observations), and initiates and maintains interplant communications of quality issues.
- Applies Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Root Cause Analysis, Statistical Analysis and Design of Experiments (DOE) to the improvement of products or processes and in solving process/product-related problems.
- Support the Plant Sterilization processes.
- Guide in the design, development, and implementation of suitable quality systems for new or existing products & processes. Facilitate the design transfer process between corporate and plant environments.
- Conduct internal audits and external (supplier, contractor, contract laboratory) audits, in QSR's and ISO9000, as well as assessments of technical, engineering, operations, & quality related areas.
- Approve and support the control and disposition of non-conformance material as per applicable procedures.
- Perform product impact assessments and the determination of non-conformances scope (i.e. bounding).
Qualifications
Education:
- A minimum of a Bachelor's degree in Engineering is required. Focus degree in Applied Science or a related technical and quality field is preferred.
Experience and Skills:
Required:
- A minimum of 2 years of work experience with a minimum of 1 year of experience in Medical Device and/or Pharmaceutical industry.
- Knowledge in QSR & ISO Standards, manufacturing process and risk management.
- Proficient in Word, Excel, Power Point, Microsoft Project, and other specialty software
Preferred:
- EIT or PE Licence preferred.
Other:
- Fully Bilingual (Spanish & English)
- 10% travel may be required
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.