Medical Device Manufacturing Quality Assurance
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious Medical Device Quality Assurance professionals looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are seeking multiple, experienced Medical Device Manufacturing Quality Operations Professionals to support a project within a regulated QMS environment (FDA QMSR / ISO 13485). These are remote positions with periodic site visits for a project with an anticipated duration of 8 months. The positions are available either as W-2 employees or contracted. There are multiple roles/workstreams to be supported including: Production & Process Controls (P&PC) Work Stream Technical Lead – QMS Manufacturing: This role provides technical leadership across manufacturing quality activities, driving compliance, remediation, and inspection readiness in alignment with FDA QMSR and ISO 13485 requirements. P&PC Work Stream Manufacturing Lead – QMS Manufacturing: This role serves as the central connector — aligning people, priorities, and deliverables across cross-functional teams to ensure consistent, compliant manufacturing execution. QMS Manufacturing P&PC Operations Lead: This role supports assessment of current state operations, drives remediation and continuous improvement, and ensures consistent, compliant execution of P&PC activities. QMS Manufacturing Lead – Process and Test Equipment: This role supports assessment of current state equipment controls, drives remediation and validation activities, and ensures compliant, reliable equipment lifecycle management. QMS Manufacturing Lead – Facilities & Utilities: Lead multi-site remediation and improvement initiatives, assess systemic gaps, and establish a scalable, inspection ready future state framework aligned with FDA QMSR and ISO 13485 requirements. Partner cross functionally and across sites to drive consistency, governance, and long-term quality system maturity. QMS Manufacturing Lead – Acceptance: This role assesses current state acceptance practices, drives remediation and standardization of acceptance criteria, and ensures consistent, compliant acceptance execution. QMS Manufacturing Lead – Quality Control: This role assesses current state QC practices, drives remediation and standardization of QC systems and controls, and ensures compliant, effective QC execution. QMS Leadership – Quality Control: This role assesses current state QC processes, supports remediation and process improvement, and ensures QC execution, data integrity, and product release activities align with FDA QMSR and ISO 13485 requirements. QMS Leadership – Nonconformance: This role supports assessment of current state nonconformance practices, drives remediation and standardization, and ensures nonconformance identification, investigation, and disposition are risk based, well documented, and compliant with FDA QMSR and ISO 13485 requirements. Manufacturing Lead – Supplier Quality: This role assesses current state supplier quality processes, drives remediation and standardization, and ensures supplier oversight, performance, and controls align with FDA QMSR and ISO 13485 requirements. QMS Leadership – Material Control: This role supports assessment of current state material control practices, drives remediation and improvement of material identification and traceability controls, and ensures consistent, compliant execution. QMS Manufacturing Lead – Material Control: This role drives compliance, traceability, and execution consistency across material identification, handling, status control, and disposition processes Qualifications:
- Experience supporting Manufacturing Quality Operations in regulated industries (medical devices preferred). Working knowledge of FDA QMSR and ISO 13485 requirements.
- Experience with Production & Process Controls, remediation, and continuous improvement.
- Familiarity with acceptance criteria, deviations, and CAPA processes.
- Demonstrated leadership capability
- Strong cross functional collaboration and communication skills. Ability to support inspection readiness and regulatory interactions
- Proven ability to develop and implement QRM deliverables.
VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence. As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced Quality, Regulatory, and validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org