Senior Quality Management Systems Manager

Jobtailor; Deutschland; Remote; EUR 100.000 - 140.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a senior QMS leader to drive global governance, harmonization, and continuous improvement across sites and functions. You will oversee CAPA, document control, change management, and quality metrics, ensuring alignment with ISO 13485 and FDA requirements.

You will lead supplier quality programs, internal audits, and the implementation of electronic QMS systems within ERP/eQMS environments, guiding cross-functional teams toward audit readiness and risk-based decision making.

Qualifikationen

• Bachelor's degree or higher in Quality, Engineering, Life Sciences or regulatory field.
• 10+ years of Quality experience in medical devices or regulated life sciences.
• 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 and QMS implementation.
• Strong experience with core QMS processes and Supplier Quality Program governance in manufacturing.
• Experience with regulatory inspections, Notified Body audits, MDSAP, and/or certification audits.
• Demonstrated ability to lead 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 worldwide.
• 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.

Aufgaben

• Lead global QMS governance, harmonization, and continuous improvement across sites and functions.
• Oversee regulatory surveillance, gap assessments, and implementation of new/revised requirements.
• Govern CAPA, change management, document control, training, Management Review, and quality metrics.
• Oversee Supplier Quality Program governance including qualification, monitoring, performance, SCARs, and supplier risk.
• Lead Internal Audit Program including planning, auditor qualification, execution, reporting, and follow-up.
• Implement and optimize electronic QMS and Document Control within 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 and risk-based decisions.
• Serve as senior QMS SME during FDA, Notified Body, MDSAP, certification audits.
• Oversee quality processes supporting customer information requests and change notifications.
• Lead, coach, and develop the QMS team and partner with site leadership to drive QMS effectiveness.

Kenntnisse

QMS Governance

Regulatory Compliance

Supplier Quality Program Management

Internal Audit Execution

CAPA Management

Change Management

Document Control

Software Assurance/Validation

ISO 14971 Risk Management

Leadership

Analytical Skills

Technical Writing

Communication Skills

Lead Auditor Certification

Regulatory Compliance Experience

Ausbildung

Bachelor's degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or related technical discipline

Tools

EQMS/ERP Quality Systems

FDA QMS Knowledge

Notified Body Audits

MDSAP

Jobbeschreibung

• 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