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.

• Demonstrate all of Flexan’s corporate values:

• We have an engaging culture.

• We embrace the rigor to be safety and quality driven in all we do.

• We embrace the choice to work here.

• We operate with transparency, ethics, and integrity.

• We consistently meet our expectations.

• We encourage innovation.

  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 30 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.

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