Manufacturing Quality Engineer I

At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as an Manufacturing Quality Engineer I, to be located in Danvers, MA.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

In this role, you will have the unique opportunity to contribute to the manufacturing of life-saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring the highest quality standards are met to save lives and recover hearts.

Responsibilities and Duties:

• Provide quality engineering support in the development and manufacturing of new and existing medical devices.

• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations.

• Lead Quality reporting such as, key performance metrics, goals, and objectives.

• Lead and support activities related to the Material Review Board.

• Lead non-conformance investigations, including cause analysis, documenting findings, and approving material dispositions. Promptly address any quality concerns through corrections, corrective/preventative actions, and Escalations.

• Monitor and analyze production information to support risk management and provide direction for corrective and preventive actions (CAPA) and/or process improvement activities.

• Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), Test method validations (TMV).

• Collaborate with manufacturing engineering to ensure the implementation of necessary process controls and validations, while adhering to established guidelines (GMP).

• Support process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products. Identify key process input variables and key process output variables.

• Support Quality Management System (process development, creating and editing new and existing SOPs). Support internal and external auditing requirements in manufacturing.

Qualifications:

Education:

• A minimum of a Bachelor's degree, preferably in an Engineering field or related technical field  

Experience and Skills:

Required:

• This position will require 0-2 years of relevant experience

• Experience working in Manufacturing/Operations

• In-depth knowledge of product/process Risk Management (FDA and ISO standards)

• Experience with a proven track record of implementing appropriate risk mitigation

• Good technical understanding of manufacturing equipment and processes

Preferred:

• Experience working in both an FDA and European regulatory environment   

• The ability to perform "hands on" troubleshooting and problem solving is preferred while quick thinking and sound judgment is highly desired  

• A thorough understanding of GMP/ISO regulations and validation regulations

• Demonstrated project management and project leadership abilities

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.