Documentation Contractor, Support
Blackbird LabsSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, MedTech, Cardiovascular, ManufacturingIndustries
Requirements
- Bachelor's degree 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
- Proficient in English verbal and written communication
- Ability to translate WI and JIBs to and from German or work with a translator
- Proficient in Microsoft Office Suite
- Solid understanding of QMS desired
- Knowledge of FDA QSR and ISO regulations required
- Willing & able to travel internationally (~5%)
- Ability to be onsite minimum of 3 times per week while training
Responsibilities
- Develop and update process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs
- Support manufacturing with engineering change orders (ECO), work instructions (WI), job instruction breakdowns (JIBs), training documentation, and creating and editing of short videos to support technical procedures
- Work with the training team to develop short videos that can supplement hands-on training
- Support the engineering team on validation protocols and reports
- Work in cross-functional teams that span global operations
- Act as a liaison with manufacturing assemblers and engineering teams to develop and edit work instructions and assembly documentation
- Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations
- Regularly report on project status 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
Skills
Technical Writing
Engineering Change Orders
Work Instructions
Job Instruction Breakdowns
Training Documentation
Video Editing
Validation Protocols
Assembly Procedures
Test Procedures
Routers
Travelers
BOMs
Process Flows
FMEAs
Johnson & Johnson
Healthcare products in pharmaceuticals and devices.
About Johnson & Johnson
Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.
New Brunswick, New JerseyHeadquarters
1886Year Founded
IPOCompany Stage
HealthcareIndustries
10,001+Employees