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Spec 3, Quality Auditing / Systems
- Location: Warwick, Rhode Island 02886
- Work model: On-site
- Posted Yesterday
- Job ID: JPC - 211642
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Job Description
Job Summary: Spec 3, Quality Auditing / Systems - QMS Documentation Remediation Specialist
Location: Warwick, RI | On-site | Contract | $70/hr
[About the Role]
Join BD Surgery as a Quality Management System (QMS) Documentation Remediation Specialist and play a pivotal role in ensuring compliance and operational excellence. You will lead the review, remediation, and harmonization of QMS documentation for a fast-paced, innovative business unit at a global leader in healthcare solutions. This is an opportunity to drive critical quality initiatives, collaborate with cross-functional teams, and strengthen your expertise in regulated environments.
[Responsibilities]
- Review, assess, and remediate controlled QMS documents (policies, SOPs, work instructions, quality manuals, forms, validation procedures, CAPA, audit, risk management, change control)
- Identify gaps, redundancies, and inconsistencies; recommend and implement improvements
- Ensure documentation aligns with FDA, ISO 13485, EU MDR, ICH Q10, and other global regulatory requirements
- Eliminate duplicate or obsolete documents, standardize terminology, and improve document usability
- Maintain remediation trackers and provide regular status updates
- Collaborate with Quality, Regulatory, Operations, Manufacturing, R&D, and SMEs to resolve documentation issues
- Support migration of documents into electronic document management systems (Veeva, MasterControl, TrackWise, etc.)
- Assist with audit readiness and inspection preparation
- Participate in remediation projects for regulatory observations, audits, or QMS transformation
- Ensure global regulations are incorporated into the QMS structure at both business unit and corporate levels
[Required Skills and Experience]
- Bachelor's degree in Engineering, Science, or related field
- 5+ years of experience in FDA-regulated industries (pharma, medical device, combination products)
- Strong experience with GMP and medical device quality systems
- Proven track record in authoring, revising, and remediating controlled quality system documentation
- Proficient in electronic document management systems
- Deep knowledge of cGMP, QMSR, ISO 13485, ICH Q10, and risk management
- Excellent technical writing, editing, and document review skills
- Acute attention to detail; ability to identify inconsistencies and compliance gaps
- Capable of interpreting complex regulatory requirements and translating them into practical solutions
[Preferred Skills]
- Direct combination product quality systems experience
- ASQ certification (CQE, CQA, CMQ/OE)
- Experience supporting QMS harmonization and large-scale remediation projects
[Benefits]
- Competitive contract rate: $70/hour
- Work on-site with a collaborative, high-performing team
- Exposure to global regulatory requirements and advanced quality systems
- Opportunity to drive change in a Fortune 500 healthcare company
- Expand your professional network and enhance your expertise in quality systems and regulatory compliance
[How to Apply]
Interested candidates should submit a current resume and a brief cover letter highlighting relevant QMS documentation and remediation experience. Qualified applicants will be contacted promptly.
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Job details
Job ID JPC - 211642
Location Warwick, Rhode Island, United States
Work Model On-site
Job Type Contractor
Experience 7 Years years
Industry Medical Equipment
Posted October 21, 2026
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