Kyle Kramer
Chester Springs
Summary
Strategic Quality Systems leader with progressive experience leading both site-level and enterprise Quality Management Systems within global medical device organizations. Proven success driving enterprise governance, FDA remediation, inspection readiness, and quality system transformation across CAPA, Management Controls, Post-Market Surveillance, Supplier Quality, Regulatory Compliance, Change Control, and Document Control. Recognized for partnering with executive leadership to strengthen regulatory compliance, improve organizational performance, and deliver sustainable quality system improvements.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Sr. Quality Assurance Manager – Enterprise Quality Systems
Integra LifeSciences
09.2024 - Current
- Enterprise Process Owner for CAPA, Nonconformance (NC), and Management Review, responsible for enterprise governance, strategic quality system improvement, and regulatory remediation.
- Led enterprise initiatives supporting FDA Warning Letter remediation across CAPA, Management Controls, Supplier Quality, Process Validation, Change Control, and Enterprise Quality Systems.
- Lead the enterprise CAPA strategy supporting FDA Warning Letter remediation and owned the Corporate Headquarters response to FDA Form 483 observations.
- Partnered with executive leadership and enterprise process owners to establish sustainable compliance strategies across multiple Quality System elements.
- Responsible for leading enterprise response to FDA Form 483 observations and Warning Letter remediation, partnering with executive leadership to establish sustainable compliance strategies across multiple Quality System elements.
- Provide strategic leadership supporting the Enterprise Compliance Master Plan (ECMP), advancing enterprise harmonization and quality system improvements across CAPA, Nonconformance, Management Controls, and related Quality System processes.
- Lead Corporate Quality inspection readiness activities supporting FDA inspections through mock inspections, SME identification and coordination, storyboard development, and inspection planning.
- Accountable to lead enterprise inspection readiness initiatives supporting FDA, Notified Body, and MDSAP inspections through governance, executive readiness, SME coordination, mock inspections, and regulatory response planning.
- Provide enterprise oversight for complex and high-risk enterprise CAPAs involving sterilization validation, endotoxin compliance, Design History File remediation, supplier quality, and other significant regulatory initiatives.
- Established the Corporate CAPA Review Board, creating a governance process for multi-site CAPAs and enterprise CAPA remediation strategies.
- Established enterprise governance through the Corporate CAPA Review Board, strengthening executive oversight, enterprise risk escalation, and cross-site accountability.
- Established the Enterprise Management Review Program, creating executive oversight of manufacturing site Quality System performance.
- Own Corporate Quality CAPA and Nonconformance performance metrics, developing recovery strategies to improve organizational performance.
- Selected to provide interim leadership of Corporate Document Control, supporting enterprise document governance, process harmonization, organizational effectiveness, and strategic Quality System initiatives.
- Life Sciences – Princeton, NJ
Quality Investigations Manager II
B. Braun Medical Inc.
07.2022 - 04.2024
- Quality Engineering leader responsible for Manufacturing Quality Engineering, Post-Market Surveillance, Supplier Quality Engineering, and Sustaining Design Assurance across a high-volume medical device manufacturing operation.
- Led a team of 9 direct and 16 indirect reports across Quality Engineering, Complaint Management, Technical Investigations, and Supplier Quality.
- Directed response to post-market signals through enterprise risk assessments, trend investigations, and CAPA/Health Hazard Evaluation escalation.
- Led investigations supporting five product recalls and more than ten Health Hazard Evaluations, providing executive leadership with investigation updates, containment activities, and corrective action plans.
- Provided Design Assurance leadership for commercialized products, supporting engineering studies, design change evaluations, and impact assessments.
- Re-engineered the Quality Investigations organization, improving accountability, operational performance, cross-functional collaboration, and regulatory compliance.
- Oversaw Quality System performance metrics including Nonconformance, Complaint, Supplier Investigation, and Trend Investigation timeliness; developed recovery strategies to improve organizational performance.
- Achieved sustained investigation performance exceeding 80% on-time closure rates, with Complaint timeliness achieved in 10 of 12 months and Supplier Investigation timeliness achieved in 12 of 12 months during 2023.
- Allentown, PA
Quality Assurance Manager / Management Representative
Cagent Vascular
03.2024 - 07.2024
- Management Representative responsible for maintaining an ISO 13485-, EU MDR-, and FDA-compliant Quality Management System.
- Responsible for the site's Quality Management System, including CAPA, Nonconformance, Management Review, Supplier Quality, Internal Audit, Complaint Handling, and Regulatory Compliance.
- Led site inspection readiness activities, successfully facilitating ISO 13485 recertification and EU MDR certification audits as front-room facilitator.
- Directed Complaint handling, Medical Device Reporting Assessments, Health Risk Assessments, and Post-Market Surveillance activities.
- Oversight of supplier qualification, supplier corrective actions, and supplier lifecycle management.
- Wayne, PA
Quality Site Leader / Management Representative
Teleflex Inc.
06.2021 - 03.2023
- Quality leader responsible for the Quality Management System supporting Class III cardiovascular medical device manufacturing operations.
- Accountable for site Quality Management System performance including CAPA, Management Review, Internal Audit, Supplier Quality, Quality Engineering, Quality Control, Regulatory Inspection Readiness, and Continuous Quality Improvement initiatives.
- Served as Management Representative and lead audit host, successfully facilitating six BSI and MDSAP audits with zero major findings.
- Led the Quality organization through acquisition integration, manufacturing transfer to Mexico, and Legal Manufacturer transfer activities.
- Partnered with Operations to reduce defects per million by approximately 50% year over year.
- Implemented risk-based AQL sampling strategies reducing inspection workload while enabling approximately 33% labor reduction during a period of significant production growth.
- Selected as one of four emerging U.S. leaders for Teleflex's executive leadership coaching program.
- Exton, PA
Quality Engineer
X-Nav Technologies
11.2018 - 06.2021
- Led site Quality System activities including CAPA, Complaint Handling, Supplier Quality, Internal Audit, Management Review, and Quality Metrics.
- Established post-market surveillance trending supporting EU MDR remediation.
- Developed supplier scorecard and supplier qualification program.
- Led the Internal Audit program supporting ISO 13485 and FDA compliance.
- Lansdale, PA
Regulatory Affairs Specialist (Contract)
Pfizer
01.2017 - 07.2017
- Managed regulatory submissions supporting Central America, Caribbean, and Mexico markets.
- Coordinated regulatory dossier compilation, quality review, translation, and health authority submissions.
- Partnered with Regulatory Affairs, GCMC, and global stakeholders to support submission strategy.
- Collegeville, PA
Education
Master of Science - Biomedical Engineering
Drexel University
07-2015
Bachelor of Science - Civil Engineering
Catholic University of America
05-2013
Skills
- Enterprise Quality Systems
- FDA QMSR (21 CFR 820)
- ISO 13485
- ISO 14971
- EU MDR
- CAPA
- Nonconformance
- Management Controls
- Management Review
- Inspection Readiness
- Internal Audit
- Document Control
- Supplier Quality
- Change Control
- Post-Market Surveillance
- Regulatory Compliance
- Enterprise Governance
- Executive Stakeholder Management
- Cross-Functional Leadership
- Organizational Transformation
- Strategic Planning
- High-Performance Team Development
- Lean Six Sigma
- Root Cause Analysis
- DOE
- Process Validation
- Risk Management
- Statistical Process Control
- Agile PLM
- SAP
- ComplianceWire
- Microsoft Office
- Minitab
Certification
- ISO 13485 Lead Auditor, BSI
- EU MDR Lead Auditor, Axeon
- MDSAP Auditor, Axeon
- Six Sigma Green Belt, Villanova
- Manufacturing Leadership Institute (MLI)
Timeline
Sr. Quality Assurance Manager – Enterprise Quality Systems
Integra LifeSciences
09.2024 - Current
Quality Assurance Manager / Management Representative
Cagent Vascular
03.2024 - 07.2024
Quality Investigations Manager II
B. Braun Medical Inc.
07.2022 - 04.2024
Quality Site Leader / Management Representative
Teleflex Inc.
06.2021 - 03.2023
Quality Engineer
X-Nav Technologies
11.2018 - 06.2021
Regulatory Affairs Specialist (Contract)
Pfizer
01.2017 - 07.2017
Master of Science - Biomedical Engineering
Drexel University
Bachelor of Science - Civil Engineering
Catholic University of America