AddressDescription
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. Learn more at https://www.jnj.com/ .
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
Principle Du ti es and Responsibili ti es :
- 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.
- Ability to work in cross-functional teams that span global operations. Proficient in English verbal and written communication. Ability to translate WI and JIBs to and from to German or work with a translator is necessary.
- Must enjoy team approach over individual contributions. Ability to be 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. Knowledge of FDA QSR and ISO regulations required.
- 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 maintaining current knowledge of medical, technical, and biomedical developments related to company products.
Qualifications
- Bachelors required in life sciences and/or writing, medical device experience preferred.
- 2+ years of technical documentation experience
- Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team
- Must be proficient in Microsoft Office Suite. Working knowledge of QMS desired.
- Willing & able to travel internationally (~5%)
Preferred Quali fi ca ti ons:
- Medical device experience
- Knowledge of FDA QSR and ISO regulations
- Working knowledge of SAP
- Knowledge of German Language
