Technical Writer - Abiomed

Disability Solutions - Danvers, MA

Full-time

Danvers, MA

Administrative and Support Services

About the position

Johnson & Johnson is currently seeking a Technical Writer to join our Quality department located in Danvers, MA. This role is open to a hybrid schedule. 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. In this position, the Technical Writer will be responsible for developing and updating process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs. The role requires collaboration with the training team to create short videos that can supplement hands-on training. The Technical Writer will work in cross-functional teams that span global operations, necessitating proficiency in English verbal and written communication. Additionally, the ability to translate Work Instructions (WI) and Job Instruction Bulletins (JIBs) to and from German or work with a translator is necessary. The ideal candidate must enjoy a team approach over individual contributions and will act as a liaison with manufacturing assemblers and engineering teams to develop and edit work instructions and assembly documentation. The Technical Writer will support and implement company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA Quality System Regulations (QSR), and ISO regulations. Knowledge of FDA QSR and ISO regulations is required. Regular reporting on project status, schedule progress, and key project metrics through scorecard presentations will also be part of the responsibilities. Furthermore, the Technical Writer will assist the engineering team in qualifying and optimizing processes and tooling via documentation for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), preventive maintenance, Gage R&R Studies, Process Capability Studies, and Designs of Experiments. Participation in the implementation of internal corrective actions and audit findings is also expected, along with maintaining accurate documentation of concepts, designs, and processes while keeping current knowledge of medical, technical, and biomedical developments related to company products.

Responsibilities

• Develop and update process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs.
• Work with the training team to develop short videos that can supplement hands-on training.
• Collaborate in cross-functional teams that span global operations.
• Translate WI and JIBs to and from German or work with a translator as necessary.
• Act as a liaison with manufacturing assemblers and engineering teams to develop and edit work instructions and assembly documentation.
• Support and implement company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.
• Regularly report on project status, schedule progress, and key project metrics through scorecard presentations.
• Assist engineering team to qualify and optimize processes and tooling via documentation for IQ/OQ/PQ, preventive maintenance, Gage R&R Studies, Process Capability Studies, and Designs of Experiments.
• Participate in the implementation of internal corrective actions and audit findings.
• Maintain accurate documentation of concepts, designs, and processes while keeping current knowledge of medical, technical, and biomedical developments related to company products.

Requirements

• Proficient in English verbal and written communication.
• Knowledge of FDA QSR and ISO regulations required.
• Ability to work in cross-functional teams that span global operations.
• Ability to translate WI and JIBs to and from German or work with a translator is necessary.
• Must enjoy team approach over individual contributions.