QMS Consultant

QMS Consultant - Contract - Boston, MA

Strengthen medical device quality systems that stand up to global regulatory scrutiny.

Proclinical is seeking a QMS Consultant to support quality management system (QMS) documentation and processes for a medical device company.

Primary Responsibilities:

The successful candidate will focus on document review, revision, creation, and risk management activities, ensuring compliance with regulatory standards such as ISO 13485, ISO 14971, and 21 CFR Part 820. The consultant will work within an Atlassian Confluence-based environment and collaborate with internal quality advisors to prioritize tasks and maintain document consistency.

Skills & Requirements:

• Working knowledge of ISO 13485:2016, ISO 14971, IEC 62366, and 21 CFR Part 820.
• Hands-on experience applying risk management principles in a medical device design and development context.
• Proficiency in drafting and revising SOPs, work instructions, and forms with precision.
• Familiarity with Atlassian Confluence, including ADF editing and version history features.
• Strong written communication skills and ability to work asynchronously.
• Independence in executing defined scopes of work with minimal supervision.
• Experience in medical device QMS documentation; pharma-only backgrounds are not suitable.

The QMS Consultant's responsibilities will be:

• Review and revise existing SOPs, work instructions, and forms to align with regulatory requirements and internal gap analyses.
• Draft targeted edits at the section level and apply changes directly in Confluence using controlled document conventions.
• Ensure cross-document consistency across nonconformance investigation and CAPA processes.
• Manage impact analysis for document changes and initiate resulting actions.
• Oversee document review, approval, and accurate cross-referencing during updates.
• Identify and resolve broken references, version conflicts, and hierarchy inconsistencies.
• Create new controlled documents (SOPs, work instructions, forms) following established naming and numbering conventions.
• Support risk management document reviews for completeness, consistency, and conformance to ISO 14971.
• Assist in clarifying risk characterization across design, development, verification, and validation stages.
• Provide advisory inputs for risk assessment gaps and documentation improvements.
• Contribute to QMS-to-QMSR transition efforts, including terminology updates and initial gap analyses.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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