Experienced Engineer Manufacturing Quality

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 an Experienced Engineer Manufacturing Quality, to be located in Danvers, MA.

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 2-4 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 p