Senior Manufacturing Quality Engineer - Abiomed

Johnson & Johnson - Danvers, MA

Full-time - Mid Level

Danvers, MA

Chemical Manufacturing

About the position

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. Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Senior Manufacturing Quality Engineer located in Danvers, MA. 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. You will provide quality engineering support in the development and manufacturing of new and existing medical devices, ensuring compliance of manufacturing processes and areas to all applicable quality system regulations. You will lead quality reporting such as key performance metrics, goals, and objectives, and support activities related to the Material Review Board. Additionally, you will lead non-conformance investigations, including cause analysis, documenting findings, and approving material dispositions. Promptly addressing any quality concerns through corrections, corrective/preventative actions, and escalations will be part of your responsibilities. Monitoring and analyzing production information to support risk management and provide direction for corrective and preventive actions (CAPA) and/or process improvement activities will be essential. You will validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and test method validations (TMV). Collaborating with manufacturing engineering to ensure the implementation of necessary process controls and validations while adhering to established guidelines (GMP) will be crucial. Supporting process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products will be part of your role. You will identify key process input variables and key process output variables, support the Quality Management System (process development, creating and editing new and existing SOPs), and support internal and external auditing requirements in manufacturing.

Responsibilities

• 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.

Requirements

• A Bachelor's degree in a relevant Engineering field is necessary.
• 6 years of experience in QA/QE in the medical device field.
• Experience with manufacturing of complex products in environmentally controlled area, catheter-based or cardiac assist devices preferred.
• Equivalent experience in the manufacturing of similar products will also be considered.
• Experience with formal problem-solving.