Sr. Manufacturing Quality Engineer

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

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Sr. Manufacturing Quality Engineer to support our capital products line. In this role, you will have the unique opportunity to contribute to 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 capital products

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

• Lead Quality reporting such as, key performance metrics, goals, and objectives for capital products

• Lead and support activities related to the Material Review Board for capital products

• 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 for capital products

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

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

• 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 for capital products

Qualifications:

• A Bachelor's degree in a relevant Electrical of Software Engineering field is necessary

• 6+ years of experience in QA/QE in the medical device field.

• Experience with manufacturing of capital equipment that is software enabled is preferred. Equivalent experience in the manufacturing of similar products will also be considered.

• Experience with formal problem-solving methodologies and deductive skills.

• Good understanding of FDA QSRs, ISO13485, ISO14971.

• Experience with handling non-conforming material and assemblies, including root cause investigations.

• Experienced in qualification of production equipment and validation of production processes.

Johnson & Johnson is a globally renowned company dedicated to improving the health and well-being of people around the world. As a leader in the medical technology industry, we are committed to developing and delivering world-class medical devices that save lives and enhance patient outcomes. Our company culture is rooted in integrity, innovation, and collaboration, and we strive to foster an inclusive and diverse work environment. We believe in putting patients first and are driven by a shared mission to recover hearts and save lives.

We are an equal opportunity employer and value diversity in our workforce. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. If you require reasonable accommodation or adjustment during the appl