Quality Documentation Specialist

Quality Document Specialist

Job Overview

• We are seeking a highly detail-oriented Quality Documentation Specialist to support the creation, review, and management of high-quality documentation within a regulated environment. This role is responsible for ensuring documentation accuracy, consistency, and compliance with organizational and regulatory standards while collaborating closely with cross-functional teams and subject matter experts. 

• The ideal candidate will have strong technical writing capabilities, experience working with quality documentation processes, and the ability to manage document control and migration activities effectively.

Key Responsibilities:

• Produce high-quality documentation ensuring accuracy, clarity, consistency, and compliance with organizational standards.

• Collaborate with subject matter experts to author and maintain project deliverables using Good Documentation Practice (GDP) principles.

• Create and submit Change Requests for new and revised documentation through the Change Control system.

• Review documents for template compliance, grammatical accuracy, spelling, and consistency in terminology.

• Conduct comprehensive reviews and evaluations of quality documents to ensure completeness and alignment with established guidelines and protocols.

• Support and contribute to process improvement initiatives that enhance team efficiency and documentation quality.

• Serve as Lead Specialist for document migration projects, including:

• Identifying documents for migration

• Completing data input spreadsheets

• Conducting data validation testing

• Maintain organized and accurate documentation records within document management systems.

Required Qualifications:

Education

• Bachelor’s Degree in Business Administration, Engineering, or a related field.

Experience

• 4+ years of experience in Technical Writing, Quality Documentation, or a related field.

• Strong experience with document creation and editing tools such as:

• Microsoft Word

• Adobe Acrobat

• Similar documentation platforms

Additional Requirements

• Ability to meet physical, cognitive, and environmental job requirements for an Office/Remote role, with or without accommodation.

• Strong organizational skills with exceptional attention to detail.

• Excellent written and verbal communication skills.

Preferred Qualifications:

• Experience with PLM systems such as:

• Windchill

• Greenlight Guru

• Experience working in Quality and Regulatory environments within the medical device industry.

• Familiarity with document control and change management processes in regulated industries.

Work Environment:

• We believe we achieve better outcomes together than apart.

• Office-based employees are expected to work onsite at least 3 days per week.

• Onsite roles require full-time presence at company facilities.

• Field-based roles are typically performed at customer or supplier locations.