Integra LifeSciences
Director, Corporate Quality Management System (QMS)
US-NJ-Princeton-100-Headquarters · Director
Sponsorship not specifiedDetected 28 days ago
SQLData AnalysisComplianceStakeholder ManagementSupply ChainCorporate LawFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingMentoringWritingMicrosoft Office
About the role
- Thinking differently is what we do best.
- Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
- In addition to enterprise leadership, this position serves as the Site Quality Leader (SQL) for the Princeton, NJ corporate office, an FDA-registered and ISO 13485-certified facility.
Responsibilities
- Own and execute the global QMS strategy, ensuring integration of document and record control, training administration, and management control processes
- In coordination and collaboration with the Enterprise Compliance Master Plan (ECMP), drive standardization, harmonization, and scalability of QMS processes across ~20 global sites with FDA-registered and/or ISO-certified quality management systems
- Lead enterprise QMS transformation initiatives, including process redesign and system enhancements
- Monitor evolving regulations and proactively implement changes across the QMS
- Establish and maintain inspection readiness programs across all sites
- Leveraging the Corporate Quality Compliance team, ensure the site maintains continuous audit readiness for FDA inspections and Notified Body audits
- Document Control & Records Management
- Define the strategy for a global QMS, and develop and maintain a unified global QMS aligned with business strategy and regulatory requirements
- Lead all regulatory inspections (FDA, ISO, MDSAP), including preparation, hosting, and response coordination
- Own and maintain the Enterprise-wide Quality Policy, Quality Manual, and corporate quality objectives
Requirements
- The employee is required to go to all areas of the company.
- The employee may be required to periodically lift and/or move up to 25lbs.
- job related tests may be required.
- The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
- Bachelor's degree in engineering, life sciences, or a related technical discipline
- Knowledge and Expertise
- Deep working knowledge of FDA QMSR / 21 CFR 820, FDA inspection and enforcement processes, ISO 13485 and global standards and regulatory frameworks
- Education and Experience
- 15+ years of progressive Quality experience within medical devices or similarly regulated life sciences industries
- Demonstrated, hands-on leadership of FDA remediation efforts, including Warning Letters or other enforcement actions
- Extensive experience in QMS design, deployment, and transformation
- Expertise in document control, training systems, change management, and records management
- Strong understanding of Management Controls, CAPA, audits, and compliance systems
- Experience with QMS technologies (TrackWise, LMS, Agile or equivalent)
- Strong analytical skills, exceptional writing and interpersonal relationship skills
- Key Competencies
- Strategic thinking, strong execution discipline, executive presence, exceptional communication skills, collaboration in complex environments, and an unwavering commitment to patient safety, product quality and:
Nice to have
- Strong experience with enterprise QMS software deployment and validation
- Proven success in global process standardization initiatives
- Ability to interface effectively with technical and non-technical stakeholders
- Strong organizational, prioritization, and multitasking abilities
- Strong oral and written communication skills and effective interpersonal skills
- Proficiency in Microsoft Office and quality systems tools
- Willingness to travel (up to ~25%)
- Ability to utilize a computer, telephone, copier, fax machine as well as other general office equipment, and industry-standard Quality System applications
Apply directly at Integra LifeSciences →Create a free account for alerts like thisView Integra LifeSciences immigration profile
This listing is sourced directly from Integra LifeSciences's careers page and normalized into a canonical job model.