The Technical Writer will work under general supervision to develop, create, and/or edit operational, instructional, maintenance, inspection, test procedures and other documentation in support of the development and manufacture of medical devices.
KEY ROLE AND RESPONSIBILITIES: • Research and document engineering processes, validation documentation, and specifications.• Develop and update process documentation including assembly procedures, test procedures, BOMs, process flows, and process FMEAs.• Collaborate openly and effectively with Engineering, Operations, Quality, and Supply Chain, among others, to ensure accuracy and completeness of content.• Produce products that conform to the company documentation and Quality Management System (QMS) standards.• Recommend formats responsive to technical, operational, quality, and customer requirements.• Must possess strong written and verbal communication skills.• Ability to multitask and prioritize to meet timelines and milestones.• Be highly organized and attentive to details.• Maintain design and development documentation to support quality and regulatory process requirements.• Support and implement company goals and objectives, policies and procedures, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), FDA QSR and ISO regulations.
Minimum Qualifications:
• Bachelor’s degree in a technical area.• Experience in technical communications, writing/ composition, or similar related field.• Must be proficient in Microsoft Office Suite.• Experience working with cross-functional project teams. Physical Demands: • The employee is occasionally required to sit; climb, balance, stoop, kneel, crouch, or crawl. • The employee must occasionally lift and/or move up to 50 pounds.
Work Environment: • The employee may be required to work in a clean room environment and is expected to follow the guidelines and rules for working in a clean room. This includes following the gowning procedure, covering hair in a hairnet, and wearing personal protective equipment as appropriate. • While performing the duties of this Job, the employee may occasionally be exposed to moving mechanical parts when in testing or production areas.
