Back to Job SearchROLE OVERVIEW
We are currently looking for a Primary QMS Work Stream Lead to join a leading organization in the Pharmaceutical and Medical Device sectors on a remote basis in the US. This is an exciting opportunity to work with a global leader that has established itself at the forefront of these innovative industries since 1998. As part of their ongoing growth, they are seeking a highly skilled professional to support critical quality management system initiatives and client projects, ensuring continued compliance and process excellence.
This role offers the chance to take a pivotal lead in QMS remediation activities, guiding cross-functional teams and contributing to strategic quality improvements within a dynamic and supportive environment.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Primary QMS Work Stream Lead will be varied however the key duties and responsibilities are as follows:
• Serve as the Subject Matter Expert (SME) for Quality System Elements (QSE) including Management Control, Document Control, and Training within the QMS remediation workstream.
• Lead and support QMS review and remediation initiatives, addressing compliance gaps and strengthening system-level quality processes.
• Provide expert guidance on root cause analysis, risk assessment, effectiveness checks, and sustainable corrective actions to resolve systemic issues.
• Develop and maintain metrics, dashboards, and reporting tools to track remediation progress, identify trends, and drive continuous improvement.
• As the QMS Work Stream Lead, you will deliver training, mentorship, and cross-functional guidance to promote ongoing adherence to quality standards and support long-term compliance.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Primary QMS Work Stream Lead we are looking to identify the following on your profile and past history:
• A Degree or higher level in a technical or scientific discipline (e.g., Pharmaceutical Chemistry / Quality Assurance / Quality Management).
• Proven 8+ years of experience in Quality Management Systems within the medical device industry or similar regulated environments.
• Extensive knowledge of QMS elements such as Management Control, Document Control, and Training, with a background in remediation and process improvement initiatives.
• Demonstrated understanding of medical device regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
• Proven experience leading or supporting cross-functional quality system remediation programs in response to audits, inspections, or regulatory findings.
WHAT’S IN IT FOR YOU?
Joining our client means being part of a global organization committed to innovation and excellence in healthcare technology. You will have the opportunity to lead impactful quality initiatives, work with industry experts, and contribute to ensuring product safety and compliance across diverse markets. Enjoy a remote working environment with supportive leadership dedicated to your professional growth.
Key Words: Quality Management System / QMS / Medical Device / Regulatory Compliance / Remediation / Process Improvement / FDA 21 CFR 820 / ISO 13485 / Cross-Functional Leadership / Risk Assessment / Continuous Improvement
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career".
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
