ANGELIA LENZ
Leawood,KS
Summary
Quality-focused professional Quality Systems Manager. Skilled in implementing and overseeing quality management systems, ensuring compliance with industry standards and regulations. Strong emphasis on team collaboration and adaptability to achieve results. Known for reliability and expertise in continuous improvement, root cause analysis, and process optimization.
Overview
15
15
years of professional experience
Work History
QUALITY SYSTEMS MANAGER
Harmar Mobility
01.2023 - Current
- Ensures that the quality systems are compliant and effective to 21CFR 820 standards, in addition to developing supporting personnel
- Respond to quality systems audits and perform internal and external audits to current regulatory standards.
- Direct the compliance programs for all cGMP areas and promote a strong Quality culture within the organization.
- Identify compliance risks and participate in the solution through ownership and collaboration.
- Reviews and maintains systems documentation processes, achieving full compliance with 21CFR820 standards and reducing audit findings by 30%
- Participates in continuous improvement initiatives, integrating best practices to optimize compliance and operational efficiency
- Conducts internal and external audits, identifying and mitigating compliance risks to uphold regulatory standards
- Directs compliance programs for all cGMP areas, promoting a rigorous Quality culture and ensuring organizational adherence to regulatory requirement
- Optimizes QMS compliance projects, enhancing cross-functional collaboration
- Leads internal and external audits, identifying compliance risks and fostering solutions through team collaboration
- Manages the RMA program, promoting automatic customer notifications and a 65% increase in returned revenue.
QUALITY MANAGER
Harmar Mobility
01.2018 - 01.2023
- Oversees quality control activities for the manufacturing facility to ensure that the highest quality standards are maintained for all processes used in the manufacture and shipment of all Class Il FDA-regulated medical devices
- Single point for all quality issues to include non-conformances (NCR), out-of-box failures, corrective actions (CAPA), incoming inspections, warranty, manufacturing quality issues, vendor quality performance, designated site FDA Quality Management Representative (QMR) for the manufacturing facility, Supplier Quality Management
- Cross functional team member for quality improvement with overseas vendors
- Initiative-taking problem-solving and analytical skills led quality control initiatives, reducing defect rates by 15% through rigorous inspections and process improvements
- Partnered with cross-functional teams to enhance vendor quality, resulting in a 20% increase in supplier performance metrics
- Implemented SOPs for incoming material inspections, ensuring compliance and improving inspection accuracy by 25%
- Developed new quality control protocols, significantly lowering out-of-box failure rates and boosting customer satisfaction
- Managed non-conformance reports and corrective actions, maintaining stringent FDA compliance and improving product reliability
Quality Control Manager
ThermoFisher Scientific
01.2012 - 01.2017
- Company Overview: Leading medical device and microbiological media manufacturer (NYSE: TMO) with $17B in revenues and 50K employees in 50 countries
- Met product quality requirements for leading medical device and microbiological media manufacturer
- Collaborate with and lead cross-functional teams to drive quality testing of dehydrated media bases and other complex products.
- Create standard operating procedures (SOPs) for product testing, laboratory procedures per CLSI, USP, and ANSI standards; and Biosafety Level Il (BSL Il) / Biosafety Level Ill (BSL Ill) lab safety protocols; orchestrate daily workloads, and train lab personnel on Master Control procedures
- Spearhead special project teams to troubleshoot and resolve quality issues
- Established a new laboratory position to increase staff coverage and accommodate an aggressive release schedule (with two extra testing days implemented per week)
- Completed Practical Process Improvement (PPI) training and shared and implemented PPI techniques with team members to propel effective problem-solving
- Leading medical device and microbiological media manufacturer (NYSE: TMO) with $17B in revenues and 50K employees in 50 countries
Quality Control Supervisor
ThermoFisher Scientific
01.2010 - 01.2012
- Directed Quality Control laboratory operations; interviewed, hired, and managed performance of up to 20 employees, defined goals and processes, and controlled $400K annual budget
- Developed and updated inspection / testing specifications; reviewed tests and measurements of bulk component pretests
- Investigated out of limit test results, reviewed device failures, and communicated possible root causes
- Developed, wrote, and implemented all Product Performance procedures for the lab per CLSI, USP and ANSI standards; maintained and enforced compliance with GMPs / SOPs and ISO regulations
- Closely monitored product flow and release to accommodate customer orders and minimize delays due to back orders
Education
Bachelor of Science - Interdisciplinary Life Sciences
Kansas State University
Manhattan, KS05.2005
Skills
- Certified Lead Internal Auditor
- Medical Device Manufacturing Quality
- Product Quality Performance Testing
- Process & Procedure Development
- Good Manufacturing Practices (cGMP)
- Supplier Quality Management
- Project Management
- Quality Laboratory Management
- Document Generation & Control (cGDP)
- Regulatory Compliance
- ISO 13485: 2016
- 21 CFR 820
- Internal quality audits
- CAPA management
- Quality metrics
- Root-cause analysis
- Customer complaint evaluations
Membership
- American Society for Microbiology (ASM)
- American Society for Quality (ASQ)
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeWork Location
On-SiteRemoteHybridImportant To Me
Career advancementWork-life balanceCompany CulturePersonal development programsHealthcare benefitsWork from home optionPaid time offPaid sick leave401k matchStock Options / Equity / Profit SharingTeam Building / Company RetreatsTimeline
QUALITY SYSTEMS MANAGER
Harmar Mobility
01.2023 - Current
QUALITY MANAGER
Harmar Mobility
01.2018 - 01.2023
Quality Control Manager
ThermoFisher Scientific
01.2012 - 01.2017
Quality Control Supervisor
ThermoFisher Scientific
01.2010 - 01.2012
Bachelor of Science - Interdisciplinary Life Sciences
Kansas State University
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