Writer: Quality Compliance (Remote)

Davita Inc.; Bethlehem (Northampton County); Remote; USD 60,000 - 80,000; Full time

Job summary

Davita Inc. is seeking a Quality Compliance Writer to join a collaborative team focused on regulatory documentation in the healthcare sector. The role involves writing and revising quality agreements and SOPs to ensure compliance with FDA regulations. This fully remote freelance position runs through the end of the year with potential for extension, targeting candidates with a background in pharmaceutical or medical device industries.

Benefits

Major medical, dental, vision, and 401K benefits

Qualifications

• 2-4 years experience in a similar role.
• Experience in regulated, medical devices/pharma preferred.

Responsibilities

• Write, revise, and maintain Quality Agreements.
• Draft and update SOPs and Work Instructions.
• Investigate and document quality issues.

Skills

Writing

Document Control

SOP Development

Education

Bachelor Degree

Job description

FREELANCE OPPORTUNITY: Quality Compliance Writer

Target Start Date: Mid July

Location: Fully Remote

Length: Through End of Year (with potential extension)

Interview Process: 1-2 rounds

About:

Our client is a recognized leader in healthcare solutions, including nutrition, pharmacy admixture, and dialysis. As part of a global group the company is committed to safety, innovation, and knowledge sharing to help eliminate treatment errors and reduce costs. To accomplish this, they make sure all their SOPs, and quality agreements are properly communicated in written form.

Department Details:

• Reports to: Quality Assurance


• Team: Distributed across multiple U.S. locations


• Environment: Collaborative, compliance-focused, with structured documentation and processes

Ideal Candidate Experience:

• Industry Background: Pharmaceutical or Medical Device


• Role Fit: Quality Generalist or Quality Analyst with documentation experience in a regulatory environment


• Key Strengths: Writing, document control, and SOP development within FDA-regulated industries

Key Responsibilities:

• Write, revise, and maintain Quality Agreements (20-30 pages, template-based with provided data)


• Draft and update SOPs and Work Instructions


• Support Quality Compliance documentation: clearly defining roles/responsibilities between client and suppliers


• Investigate and document quality issues, helping implement preventive actions

Writing Expectation:

• Approximately 25-30% of documentation will require net-new (original) content creation


• Remaining work involves adapting or updating existing templates with project-specific data


• No AI writing tools permitted in the creation of official documentation

Experience:

Bachelor Degree

2-4 years experience in similar role

Regulated, medical devises/pharm experience, preferred







DIGITAL PEOPLE IS PROUD TO OFFER OPTIONAL MAJOR MEDICAL, DENTAL, VISION AND 401K BENEFITS.























#LI-SS2 #LI-REMOTE

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