Manufacturing Quality Engineer II - Abiomed

Johnson & Johnson - Danvers, MA

Full-time

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 highly-motivated Manufacturing Quality Engineer II based 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 support 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. Additionally, you will validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and test method validations (TMV). Collaboration with manufacturing engineering will be essential to ensure the implementation of necessary process controls and validations in alignment with industry standards (GMP). You will also support the Quality Management System by developing processes and creating and editing new and existing SOPs, as well as supporting 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.
• Support non-conformance investigations, including cause analysis, documenting findings, and approving material dispositions.
• Promptly address any quality concerns through corrections, corrective/preventative actions, and escalations.
• Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and test method validations (TMV).
• Collaborate with manufacturing engineering to ensure the implementation of necessary process controls and validations in alignment with industry standards (GMP).
• 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 related Engineering field.
• 2 years of experience in QA/QE in the medical device field.
• 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.