Gardening - Vegetable and Native Plants
ANGELA STEPHENS
Taylorsville,KY
Summary
Seasoned Quality Management Professional with over 30 years of experience in the medical device and pharmaceutical sectors. Demonstrates strong expertise in root cause analysis, CAPA, and product quality investigations, ensuring strict compliance with ISO 13485 and 21 CFR 820. Recognized for exceptional skills in lifecycle management and post-market surveillance, facilitating cross-functional collaboration to implement quality solutions that enhance patient safety. Dedicated to advancing industry standards and improving operational efficiency.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Quality Manager, Post-Market
Avantor
10.2021 - Current
- Established and executed a Post-Market Surveillance process for EU MDR/IVDR compliance.
- Aligned corrective and preventive actions with identified root causes to enhance efficiency.
- Led creation of a comprehensive Global Risk Management Process aligning with ISO 30001 and ISO 14971 standards.
- Trained and mentored cross-functional teams to apply risk management strategies.
- Established a global adverse event reporting process, including detailed work instructions for consistent reporting across all regions.
Post Market Quality Operations Manager
Becton Dickinson
08.2020 - 10.2021
- Directed quality investigations and root cause analysis in collaboration with post-market surveillance teams to boost compliance.
- Oversaw complaint management process from intake to FDA MDR filing for Life Sciences Segment.
- Managed team of 40, reducing process complexity and achieving low failure rates.
- Implemented process improvements that reduced complaint closure times, minimized late MDR filings, and increased overall efficiency.
- Supported audits and inspections by regulatory and notified bodies, and contributed to management reviews and internal audits.
- Streamlined adoption of IMDRF codes to standardize MDR submission processes globally.
Director of Quality Assurance
Predictive Biotech
11.2018 - 08.2020
- Directed CAPA processes to enhance root cause analysis functions.
- Oversaw implementation of quality assurance strategies, ensuring excellence in CAPA management and regulatory compliance.
- Managed key quality functions, including internal audits, product inspections, and final quality control testing.
- Ensured comprehensive training for all personnel.
- Ensured strict adherence to HIPAA regulations for sensitive data handling.
- Tracked supplier quality compliance, and maintained an approved vendor list.
- Facilitated FDA inspections.
Senior Laboratory Operations Manager
Nelson Laboratories, LLC
03.2017 - 11.2018
- Directed daily operations for microbial identifications and packaging, overseeing 22 direct reports.
- Boosted key employee retention through structured career guidance, effective succession planning, and supervisory development.
- Implementing training programs that improved turnaround time by 27% in packaging testing, and quality by 50% in microbial identification.
- Managed annual budgets, and aligned financial and operational directives with company goals.
- Improved efficiency by optimizing production, personnel, and equipment utilization.
- Directed successful $1.2M venture to broaden testing options, delivering on schedule.
Education
Bachelor of Business Administration -
Westminster College
Salt Lake City, UT06.2012
Associates of Science - Biology
Salt Lake Community College
Salt Lake City, UT06.1998
Skills
- Root Cause Analysis
- CAPA
- Corrective actions
- Preventive actions
- Quality Control Investigations
- ISO 13485
- 21 CFR 820
- ISO 14971
- Post-Market Surveillance
- Compliance monitoring
- Vigilance
- Risk Management
- Quality Auditing
- Continuous improvement
- Adverse Event Reporting
- Operational Management
- Team Leadership
- Cross-functional team leadership
- Trackwise
- SAP
- MasterControl
- EtQ
- LIMS
Certification
- Certified Quality Engineer (ASQ – CQE)
- Lean Six Sigma Green Belt
- Certified Quality Auditor (ASQ – CQA)
- National Registry of Certified Microbiologist (NRCM)
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeLocation Preference
RemoteHybridImportant To Me
Work-life balanceCompany CultureWork from home optionPaid time offInterests
Reading and Audio Books
Hiking and exploring
Software
Trackwise
MasterControl
Microsoft Excel
Microsoft Office