Lead global QMS governance, harmonization, and continuous improvement across sites and functions.
Lead regulatory and standards surveillance, gap assessments, and implementation of new or revised requirements.
Provide governance of CAPA, change management, document control, training, Management Review, and quality metrics.
Govern and oversee the Supplier Quality Program, including qualification, monitoring, performance, SCARs, and supplier risk.
Lead the Internal Audit Program, including audit planning, auditor qualification, execution, reporting, and follow-up.
Lead implementation and optimization of electronic QMS and Document Control systems within the ERP/eQMS environment.
Provide Quality oversight for computer software assurance/validation of quality-impacting systems.
Drive QMS performance, inspection readiness, and continuous improvement using metrics, trends, and risk-based decision-making.
Serve as a senior QMS subject matter expert during FDA, Notified Body, MDSAP, certification, and customer audits.
Oversee quality processes supporting customer information requests and change notifications.
Lead, coach, and develop the QMS team and partner with site and functional leadership to drive Quality System effectiveness.
Requirements Bachelor's degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or related technical discipline.
10+ years of Quality experience in the medical device or regulated life sciences industry.
5+ years leading QMS programs or major Quality System initiatives.
5+ years of people-management experience.
Advanced knowledge of ISO 13485 and FDA medical device QMS requirements.
Experience with global regulatory requirements, regulatory/standards gap assessments, and QMS implementation.
Strong experience with core QMS processes and Supplier Quality Program governance in a manufacturing environment.
Experience with regulatory inspections, Notified Body audits, MDSAP, and/or certification audits.
Demonstrated ability to lead complex, cross-functional and multi-site initiatives.
Strong leadership, analytical, communication, technical writing, and problem-solving skills.
Global or multi-site medical device QMS experience.
Knowledge of EU MDR and medical device requirements in Canada, Australia, Brazil, Japan, Switzerland, and the UK.
Experience with eQMS/ERP Quality systems, software assurance/validation, and ISO 14971 risk management.
Lead Auditor, ASQ CMQ/OE, CQA, RAC, or equivalent certification preferred.
Core Competencies Demonstrates extensive expertise in Quality Management Systems (QMS) governance, regulatory compliance, and continuous improvement within the medical device industry. Proven ability to lead cross-functional teams, manage supplier quality programs, and ensure inspection readiness through effective metrics and risk-based decision-making.
Highest-signal resume keywords Quality Management Systems (QMS) Governance
ISO 13485 Knowledge
Regulatory Compliance Experience
Supplier Quality Program Management
Lead Auditor Certification
ATS Optimization Keywords Hard Skills Quality Management Systems (QMS)
Regulatory Gap Assessments
Document Control
CAPA Management
Change Management
Internal Audit Execution
Software Assurance/Validation
ISO 14971 Risk Management
EQMS/ERP Quality Systems
Quality Metrics Analysis
Soft Skills Leadership
Analytical Skills
Communication Skills
Technical Writing
Problem-Solving Skills
Certifications & Qualifications Lead Auditor
ASQ CMQ/OE
CQA
RAC
Industry Keywords Medical Device Industry
Regulated Life Sciences
FDA Compliance
Notified Body Audits
MDSAP
EU MDR
Global Regulatory Requirements
Supplier Risk Management
Quality System Effectiveness
Cross-Functional Initiatives
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