Quality Assurance Technical Writer
Quality Assurance Technical Writer
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Job Description
Overview
Job Summary
Create revise and review product technical documentation (including product design validation and regulatory submissions). Review documentation to ensure that all quality and regualtory requriements are met. Supports activities which lead to and maintain both domestic and international regulatory approval to market devices. In addition performs a variety of managerial tasks and projects to ensure quality system compliance with US FDA Quality System Regulations EU IVDR MDSAP Canadian Medical Devices Regulations IVD Directive (98/79/EC) other applicable international medical device regulations and ISO 13485.
Responsibilities
Key Accountabilities
- Create revise and review product technical documentation (including product design validation and regulatory submissions).
- Create revise and review company procedures to align with global reguations.
- Learn the companys products in sufficient detail in order to be able review product documentation.
- Serve as quality technical representative on cross function teams including product development teams.
- Support revision of technical documentation for IVDR (EU 2017/746) product certification.
- Revise and approve product documentation as needed to support global regulatory submissions.
- Support action item activities related to CAPA and change control.
- Support other quality system activities.
- Stay up-to-date on global IVD regulations.
- Performs other duties and responsibilities as assigned
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Networking/Key Relationships
- This role will work often with cross functional teams including the following:
- Project Management
- R&D and MTS (Manufacturing Technial Support)
- Operations
- RA/QA counter parts globally
Qualifications
Minimum Knowledge & Experience required for the position:
Education:
- Bachelors degree in a science related field (ex. biology biomedical molecualr biology)
Experience:
- Five (5) or more years of experience in quality assurance in a pharmaceutical or medical device industry. Three (3) years of experience in technical writing. Experience with IVDR technical documentation preferred.
- Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities:
- Experience creating/revising documentation in alignment with global medical device regulations: 21 CFR Part 820 ISO 13485 MDR/IVDR (2017/745 and 2017/46)
- Strong interpersonal organizational and communication skills
- Self-starter; ability to participate in cross-funcitional teams
- Ability to set objectives and organize work to achieve goals
- Must be able to work within an evolving environment
- Must be able to accept change to work schedule on a daily basis
- Excellent communication skills both oral amd written
- Well-versed in Microsoft Office applications
- Experience using MasterControl preferred
Travel Requirements:
- Travel is not routinely required for this position (<5%)
Employment Type
Full-Time
