Renee Kanga
Medical Device Quality Professional
Austin,TX
Summary
Innovative, accomplished, results oriented medical device quality professional with over 15 years of progressive experience over a broad range of functions within the quality department.
Collaborative and team-oriented with excellent communication and interpersonal skills to foster strategic partnerships.
Certified CQM/OE, CQE and ISO 13485:2016 lead auditor with proven ability to manage multiple projects and cross-functional teams with a strong technical background in quality management systems, internal audits, risk management/FMEAs and non-conformance/root cause analysis and disposition.
Established a high level of understanding for maintaining a quality management system in a medical device, pharmaceutical and nutritional supplement industries. Well vast in the following standards and regulations respectively: ISO 13485:2016, 14971:2019, 19011:2018, 9001:2015, FDA 21 CFR parts 820, 210, 211,111 and Goal is to continue efforts in understanding the ever-changing and rigorous regulatory standards in these industries and leverage that knowledge in supporting new product development and ultimately change lives for the better.
Overview
10
10
years of professional experience
7
7
years of post-secondary education
7
7
Certifications
Work History
Quality Systems Compliance - Audit Program Manager
Beckton Dickinson - Medical
Sandy , UT
02.2020 - Current
- Responsible for creation of audit schedule and execution of internal audit program.
- Responsible for hosting external audits, prepping audit checklists, gathering relevant SMEs and audit responses for nonconformities issued.
- Delivered subject matter expertise for internal and external customers on compliance best practices and quality control.
- Mentored, trained, and managed 50+ internal auditors in conducting internal audits for conformance to regulatory bodies, customer requirements and industry standards. Oversaw execution and implementation of all audit corrective action plans.
- Evaluated audit non-conformances against assessed risk to identify and resolve quality and process issues in collaboration with auditees.
- Wrote and implemented audit procedures to standardize processes and streamline workflow.
- Performed gap assessments on newly issued or revised regulatory standards and corporate procedures and created action plans to close identified gaps.
- Prepared and presented comprehensive reports to upper management and audit team, covering issues and recommendations.
BD Global Health Fellow
Beckton Dickinson
Nyeri , Kenya
01.2020 - 02.2020
- Lab Quality Consultant for Consolata Hospital Mathari lab in Nyeri, Kenya for BD-PEPFAR Labs for Life Program.
- Led planning and achievement of SLMTA checklist goals and objectives consistent with ISO 15189:2012.
- Trained and mentored lab staff on newly implemented quality manual.
- Implemented new CAPA and LIMS systems.
- Prepared presentations and provided training for newly implemented quality programs - CAPA and LIMS.
- Administered job knowledge assessments and competency testing for certification-level training.
- Conducted gap-assessments on both laboratory regulations and standards and lab quality programs and created action plans to close identified gaps.
- Supervised staff to coordinate quality assessments, implement quality plans and assess effectiveness of executed plans.
New Product Development Quality Engineer II
Beckton Dickinson - BARD
Salt Lake City , UT
06.2018 - 01.2020
- Performed reviews of Complaint investigation, CAPAs, OOSs and process deviations to ensure that regulatory, quality and technical/functional requirements are fully met and satisfied.
- Worked closely with design engineering to define hybrid acceptance criteria for new components/parts to create master validation and verification plans for new or improved infusion devices.
- Responsible for constructing and updating risk assessments documents and FMEAs for product lines that I supported.
- Participated in design reviews for new product development and offered quality perspective inputs e.g human factors for easy usability of infusion devices.
- Created and carried out verification and validation testing protocols and generated reports from subsequent results.
- Approved process validation requirements (IQ, OQ and PQ) and equipment qualifications for new components or new equipment introduced to manufacturing
- Led investigation, resolution and prevention of new or improved product and process non-conformances.
- Conducted research for failure investigations pertaining to design defects, field returns and customer complaints in order to determine root cause and resolve identified issues.
- Sat as an active member of the material review board.
- Facilitated process improvements by leveraging QMS metrics for opportunities.
- Conducted gap assessments on newly released or updated standards and regulations.
- Lead and support key post market quality efforts within BD advanced peripheral business unit
- Coordinated investigation of post market trend trigger events in collaboration with other functions (R&D engineering and manufacturing)
- Devised and implemented quality acceptance plans and methods for inspecting, testing and evaluating precision and accuracy of components and production equipment.
- Conduct regular internal audits to ensure compliance of ISO 13485 and 21 CFR 820 and other medical device regulations
Research and Development Formulation Scientist
Reckitt Benckiser
Salt Lake City , UT
11.2016 - 05.2018
- Responsible for new product development for RB's VMS brands; Airborne and Digestive Advantage; which involved sourcing, qualifying and validating new raw materials.
- Conducted research on raw materials and nutritional supplement delivery formats to meet growing needs of consumer and incorporated new trends into RB's brands. E.g. Project Thyme - Airborne in liquid format.
- Developed and ran pilot trials and blend studies on formulation to ensure potency and stability before finalization of product formula and transfer to manufacturing.
- Conducted plant trials to generate stability data to support product shelf life.
- Coordinated testing with the R&D lab by writing testing and stability protocols and generating reports of the subsequent results.
- Completed tech transfer documentation to support product launch.
- Worked closely with other cross functional teams such as medical, quality, regulatory and laboratory to support product development and process improvement.
- Actively participated in product innovation and consumer visualization efforts.
- Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
Research and Development Analytical Chemist
Reckitt Benckiser Inc
Salt Lake City , UT
03.2016 - 11.2016
- Responsible for new product development testing, method development and validation.
- Wrote test methods and SOPs to validate laboratory systems (cGLP) and process improvement efforts.
- Conducted weekly maintenance and troubleshooting for instruments such as HPLCS, GC's, pH meter, centrifuge, sonicators, analytical balance and IC-PMS.
- Prepared standards, references and reagents for testing and managed their documentation from receipt to expiration.
- Reviewed testing work packets for accuracy and data integrity.
- Transferred test methods to QC upon completion of validation.
- Participated heavily in departmental and cross-functional teams to problem resolute to meet daily needs and smooth running of R&D and QC laboratories.
- Chaired teams involved in improving lab processes such as document control process and review.
- Provided training to new staff on SOPs and test methods.
Quality Control Chemist - Team Lead
Actavis
Salt Lake City , UT
03.2014 - 03.2016
- Performed test method validation to ensure most effective dug extraction methods for drug products tested and to assess product effectiveness and alignment with designed purpose.
- Responsible for testing of OTC and RX class II, II and IV pharmaceutical drugs such as fentanyl, lidocaine, clonidine and oxybutynin in skin patch delivery formats in QC lab.
- Reassessed quality control measures at systemic level to proactively identify non-conformances.
- Conducted investigations of out of norm findings such as foreign material, out of specification and deviations.
- Reviewed testing results and documentation, and generated lab reports.
- Constructed team testing schedule and coordinated drug testing of 3 shifts in the QC lab.
- Conducted weekly maintenance and calibration for instruments such as distek, viscometer, pH and conductivity meters among others and maintained their documentation.
- Participated in lab mock audits to ensure lab was in a state of readiness and complied with cGLP and state and federal regulations
- Advised and led process improvement teams with deliberation, leadership and strategic planning to ensure continuous improvement within lab.
- Conducted monthly safety audits to ensure safe working environment for lab personnel and compliance with state and federal regulations.
- Liaised between quality control and other departments and contractors, providing project updates and consultation.
Quality Assurance Team Advisor (Manager)
Schreiber Foods
Logan , UT
11.2011 - 06.2013
- Communicated directly with QA team to resolve user-reported problems, questions and complaints.
- Reassessed quality control measures at systemic level and led internal audits to proactively identify non-conformances and ensure customer satisfaction.
- Adapted procedures to mitigate quality issues and improve deficiencies by ensuring process controls are spelled out and understood.
- Responsible for release of all manufactured batches from Smithfield plant.
- Ensured that plant and support associates upheld food quality standards by closely monitoring our stability and environmental monitoring programs.
- Created quality assurance programs and control policies such as metal detection (HACCP) to ensure that plant met federal and state regulations.
- Rolled out training and ensured that all associates were fully trained on our quality programs, SQF and cGMP practices.
- Improved plant's efficiency by implementing programs such as 5S to production floor, quality control labs and incoming inspection and warehouse areas.
- Increased profitability by reducing waste and implementing re-worked product and scrap collection of cheese for animal sales.
- Managed quality department's documentation - quality checks, spot check-recall, CAPA's, customer complaints etc.
Education
Master of Science - Clinical Research Administration
George Washington University
Washington, DC 05.2021 - Current
M.D. - Medicine
American University of Antigua ( Incomplete)
Antigua And Barbuda 08.2008 - 07.2010
Bachelor of Science - Human Biology
University of Kansas
Lawrence, KS 08.2004 - 05.2008
Skills
Quality Systems Auditorundefined
Accomplishments
- Quality Systems Auditor
- Process Validation (IQ/OQ/PQ)
- Design Control, Validation and Verification
- New Product Development
- CAPA, Non-conformance/Root Cause Analysis and Disposition
- Quality Management System
- Risk Assessment and Management/FMEAS
- 21 CFR parts 101, 111, 210, 211 and 820
- ISO 13485:2016,14971:2019, 19011:2018 and 9001:2015
- EU MDR and MDD
- Manufacturing Lot Release Activities
- Quality Metrics & Statistical Analysis using Minitab
- Continuous Process Improvement
- Process and Systems Gap Assessment
Certification
CQM/OE - ASQ
Affiliations
- Amsden Book Award Recipient, Honor issuer: University of Kansas
- Board Member and Advisor - Women's Restore Hope Network
- Community Volunteer: Women for Women International
- Trainer: Big Brother Big Sister Foundation, Inc.
- Fundraising Coordinator: Children of the Nations
- Member, University of Kansas Alumni Association
- Member, Society of Women Engineers
- Member, Young Black Professionals – SLC Chapter
Hobbies
- Volunteering and Community Involvement
- Travelling
- Arts and Culture
- Cooking
Timeline
Master of Science - Clinical Research Administration
George Washington University
05.2021 - Current
Quality Systems Compliance - Audit Program Manager
Beckton Dickinson - Medical
02.2020 - Current
BD Global Health Fellow
Beckton Dickinson
01.2020 - 02.2020
New Product Development Quality Engineer II
Beckton Dickinson - BARD
06.2018 - 01.2020
Research and Development Formulation Scientist
Reckitt Benckiser
11.2016 - 05.2018
Research and Development Analytical Chemist
Reckitt Benckiser Inc
03.2016 - 11.2016
Quality Control Chemist - Team Lead
Actavis
03.2014 - 03.2016
Quality Assurance Team Advisor (Manager)
Schreiber Foods
11.2011 - 06.2013
M.D. - Medicine
American University of Antigua ( Incomplete)
08.2008 - 07.2010
Bachelor of Science - Human Biology
University of Kansas
08.2004 - 05.2008
CQM/OE - ASQ
CQE – ASQ
CQA – ASQ
Certified Lead Auditor (NSF)
Six Sigma Green Belt
CGLP
CGMP
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