Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives.
Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.
Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements.
Management Responsibility as required by ISO13485/9001 and ensuring specific economic operator roles are fulfilled.
Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency.
Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.
Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS).
Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.
Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements.
Coach and mentor emerging Quality leaders and technical experts to build organizational capability and ensure robust succession planning.
Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders.
Manage departmental budget and resources effectively, identifying opportunities to drive cost efficiencies while maintaining compliance and quality standards.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required.
12+ years’ experience in Medical Device quality system management
Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR
Experience/knowledge of Supplier Quality Management Processes, auditing, Change Management, Root Cause Analyses, Corrective/Preventive Actions
Experience/knowledge with distribution processes, logistics and supply chain operations
Proven ability to lead and develop high-performing teams and build future technical and people leaders.
Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
Excellent collaboration, influence, and communication skills across functional and organizational boundaries.
Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
Experience leading in a matrixed, global organization and managing competing priorities effectively.
Commitment to scientific integrity, compliance excellence, and continuous improvement.
Desirable certifications include ASQ –CQA, ASQ-CQE, ASQ-SWQE, ASQ-CQM
Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline is preferred.
Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise.

Benefits

medical, dental, vision, life, and disability insurance
401(k) plan
employee assistance program
Employee Stock Purchase Plan
paid time off (including sick time)
paid Holidays

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality System managementSupplier Quality Management ProcessesAuditingChange ManagementRoot Cause AnalysisCorrective ActionsPreventive ActionsData analyticsProcess improvementQuality Management System (QMS)

Soft Skills

LeadershipCollaborationInfluenceCommunicationAnalytical skillsProblem-solvingCoachingMentoringContinuous improvementStrategic alignment

Certifications

ASQ – CQAASQ – CQEASQ – SWQEASQ – CQMLean Six SigmaPMPAdvanced degree (MS, PhD, MBA)ISO 9001 certificationRegulatory compliance certificationQuality assurance certification