J&J Family of Companies
Quality Engineer II
J&J Family of Companies, Warsaw, Indiana, United States, 46580
Johnson & Johnson MedTech Orthopedics (a member of Johnson & Johnson Family of Companies), is currently seeking a Quality Engineer II to join our outstanding team located in Warsaw, Indiana!
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.
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.
The Quality Engineer II position will apply leadership, interdependent partnering, and Quality Engineering expertise to ensure efficient and effective quality & compliance and continuous improvement in our end-to-end business with a focus in manufacturing operations. They will also apply these principles and problem-solving skills to develop and optimize products & processes that are aligned with the overall business vision. This individual will support process containment and bounding of nonconforming product. They also apply appropriate risk management to prevent unanticipated failure modes and improve capability of processes. They pioneer methods and techniques to be used or adapt standard methods to meet needs. They coordinate phases of work internally and externally and may direct activities of technical support staff. This role supports new product introduction, continuous improvement initiatives, and base business products and processes.
Key Responsibilities:
Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, GxP, and other applicable regulatory requirements
Identifying and supporting resolution of Quality Issues. Owns and supports investigation, bounding, actions, reviews, and approval of non-conformances, CAPAs, and audit findings.
Developing, tracking, and reporting quality metrics to improve Quality Systems.
Conduct risk-based decision making and create and update risk documentation and manufacturing control plans.
Use lean principles to make process improvements.
Perform validation activities and support NPI projects as part of design transfer.
Handle conflict resolution as it relates to technical situations.
Coaching others on quality event investigation processes.
Qualifications
Education:
A Bachelor’s degree or University equivalent in Engineering or related scientific field required.
Experience and Skills:
Required:
A minimum of two (2) years of experience in a GMP and/or ISO regulated industry and experience with a FDA regulated environment is required.
Experience supporting a production environment.
Process Validation expertise.
Preferred:
Strong knowledge of statistical software packages and the ability to facilitate decision making practically, graphically, and analytically.
Project management/leadership experience or certification.
Training or certification in Lean or Six Sigma Methodologies.
Technical understanding of manufacturing and inspection equipment and processes.
Strong organizational skills.
Critical thinking and attention to detail.
Excellent verbal communication and technical writing.
Ability to analyze and present data that facilitates & drives decision making.
Perform "hands on" problem solving.
Other:
Ability to proficiently communicate both verbal and written in English.
This position will be located in Warsaw, IN 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.
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.
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.
The Quality Engineer II position will apply leadership, interdependent partnering, and Quality Engineering expertise to ensure efficient and effective quality & compliance and continuous improvement in our end-to-end business with a focus in manufacturing operations. They will also apply these principles and problem-solving skills to develop and optimize products & processes that are aligned with the overall business vision. This individual will support process containment and bounding of nonconforming product. They also apply appropriate risk management to prevent unanticipated failure modes and improve capability of processes. They pioneer methods and techniques to be used or adapt standard methods to meet needs. They coordinate phases of work internally and externally and may direct activities of technical support staff. This role supports new product introduction, continuous improvement initiatives, and base business products and processes.
Key Responsibilities:
Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, GxP, and other applicable regulatory requirements
Identifying and supporting resolution of Quality Issues. Owns and supports investigation, bounding, actions, reviews, and approval of non-conformances, CAPAs, and audit findings.
Developing, tracking, and reporting quality metrics to improve Quality Systems.
Conduct risk-based decision making and create and update risk documentation and manufacturing control plans.
Use lean principles to make process improvements.
Perform validation activities and support NPI projects as part of design transfer.
Handle conflict resolution as it relates to technical situations.
Coaching others on quality event investigation processes.
Qualifications
Education:
A Bachelor’s degree or University equivalent in Engineering or related scientific field required.
Experience and Skills:
Required:
A minimum of two (2) years of experience in a GMP and/or ISO regulated industry and experience with a FDA regulated environment is required.
Experience supporting a production environment.
Process Validation expertise.
Preferred:
Strong knowledge of statistical software packages and the ability to facilitate decision making practically, graphically, and analytically.
Project management/leadership experience or certification.
Training or certification in Lean or Six Sigma Methodologies.
Technical understanding of manufacturing and inspection equipment and processes.
Strong organizational skills.
Critical thinking and attention to detail.
Excellent verbal communication and technical writing.
Ability to analyze and present data that facilitates & drives decision making.
Perform "hands on" problem solving.
Other:
Ability to proficiently communicate both verbal and written in English.
This position will be located in Warsaw, IN 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.