MEDIcept Inc. · 1 day ago
Principal Consultant Quality Systems
United States
Full-time
Remote
Lead/Staff
12+ years expMEDIcept Inc. is a consulting firm specializing in Regulatory, Quality, and Clinical affairs for the medical device and biotechnology industries. The Principal Consultant, Quality Systems is responsible for leading quality engagements, providing strategic technical support, and ensuring compliance with regulatory standards.
Medical Device
No H1B
Hiring Manager
Conner Harman
Responsibilities
Serve as a trusted advisor to clients, keeping a ‘pulse’ on their evolving needs and suggesting technical opportunities for expanded MEDIcept support based on expertise
Proactively identify client pain points related to Quality compliance during active projects and translate them into actionable business opportunities
Architect high-level quality strategies and remediation frameworks – including QMS development and FDA readiness plans – that demonstrate immediate value to prospects
Provide the initial technical framework for new projects and add-on services to ensure technical accuracy before contract finalization
Lead and support complex internal, supplier, MDSAP, ISO 13485, and CE Mark audits
Serve as an expert in FDA inspection preparation activities, delivering training, conducting mock audits, and leading remediation efforts
Develop, maintain, and remediate QMS compliance in alignment with FDA QSR/QMSR, ISO 13485, and MDSAP requirements
Serve as the senior-most Subject Matter Expert (SME) for high-stakes quality remediations, including responses to 483s and Warning Letters
Ensure strategic alignment between client quality management systems and relevant regulatory standards (ISO 13485, 21 CFR 820/QMSR, MDSAP)
Provide hands-on quality support, including serving and interim or adjunct quality staff, as needed to support client engagements
Manage multiple concurrent projects to successful, on-time, and on-budget completion
Identify areas for process improvement, remediation, or additional contracted resources during project execution
Participate in industry events and digital outreach to position MEDIcept as a leader in complex compliance and innovation
Mentor junior and senior staff and contribute to MEDIcept’s through leadership and overall service excellence
Qualification
Required
Bachelor's degree or equivalent combination of education, experience, and training
12-15+ years' experience in medical device quality systems, with a strong focus on auditing and remediation
Expert knowledge of US FDA regulatory requirements (21 CFR 820/QMSR), ISO 13485, MDSAP (ISO 9001, EU MDR 2017/745 & EU IVDR 2017/746, a plus)
Deep experience in QMS implementation, maintenance, and large-scale remediation projects
Extensive experience conducting or leading audits and supporting successful FDA inspections, including inspection readiness activities, FDA-style audits, training, and post-inspection remediation
Exceptional formal presentation and technical writing skills, with the ability to influence audiences ranging from Engineers to C-Suite executives
Strong organization, analytical, and problem-solving skills, with a high level of attention to detail
Preferred
Lead Auditor certification (ISO 13485, MDSAP and ISO 9001)
ASQ CQA
RAC certification
Prior experience in a senior-level consulting role focused on strategic account growth and technical relationship management
Former FDA experience strongly preferred, such as FDA Investigator, Compliance Officer, Reviewer, or equivalent regulatory role
Project Management experience a plus
Company
MEDIcept Inc.
MEDIcept, Inc. is a premier FDA consulting firm and full-service CRO specializing in medical devices, digital health, SaMD, combination products.
11-50 employees
Funding
Current Stage
Early StageRecent News
Med-Tech Innovation
2024-05-23
Company data provided by crunchbase