Senior Quality Management Systems Manager

• 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