- Develop, write, and maintain clear and concise Work Instructions for production processes based on engineering specifications, process validations, and manufacturing requirements.
- Collaborate closely with cross-functional teams including Engineering, Quality, and Production to gather information and ensure documentation reflects current best practices
- Ensure all documentation complies with applicable regulatory and quality system standards (FDA, ISO 13485, etc.).
- Format documents according to internal templates and document control requirements.
- Participate in document reviews, revisions, and approvals using the company's document control system.
- Support continuous improvement initiatives by updating and improving existing documentation.
- Conduct floor visits and discussion with subject matter experts to ensure accuracy and usability of instructions.
- Assist in training production staff on recent or revised Work Instructions when necessary.
Preferred candidate profile
- Ability to write clear, concise, and structured documentation tailored for manufacturing operators.
- Skilled in creating step-by-step instructions, visual aids, and standardized formatting.
- Strong interpersonal skills for working with cross-functional teams (Design, Engineering, Quality, Production)