POSITION TITLE: Quality Specialist II-Technical Writer

BUSINESS UNIT: Medical Device and Consumer Wellness

LOCATION: Remote

SUMMARY: The Quality Specialist II technical writer position at Owlet is a hands-on role responsible for generating the design history file documents with input from a cross-functional team for medical device and consumer wellness products. This position will work closely with product and project managers for product changes and new product development to ensure timelines are met.

PRIMARY RESPONSIBILITIES:

• Participate in all design phases of the development of Owlet products, both Medical Device and Consumer Wellness, writing and revising applicable documentation required per the company QMS.
• Identifies inconsistencies and revises quality documentation to ensure GDP across company records.
• Reviews incoming quality records for accuracy and consistency across the product file.
• Participates in the development of standard QMS tools and checklists to drive the accurate capture of quality data for design and development.
• Collaborate closely with Engineering, Product and Design teams to deliver accurate and complete quality documentation for each product. 
• Maintains DHF and Technical Documentation assessing and updating controlled documents as changes are made.
• Develops streamlined processes and templates for Design Control through integration with Owlet’s eQMS Arena.

POSITION REQUIREMENTS:

• Associates Degree with 5 years of experience or Bachelors degree with 3 year experience
• Experience with Medical Device Design Control required, experience with software development a plus
• Organized and detail-oriented
• Adept with Microsoft Office products, particularly Excel and Word; demonstrated database, spreadsheet, and word processing skills
• Technical writing skills required
• Experience with document control and process development using eQMS software such as Arena or MasterControl strongly preferred