Kamila Allen
Roxbury,CT
Summary
Quality and Regulatory Affairs Manager with 12 years of documented quality control success. Develops specific and measurable goals, improvements, and standards to continuously and consistently improve quality and reduce and eliminate errors. Successfully audits and maintains product accuracy and timely delivery resulting in customer satisfaction. Initiates quality-related SOP training and enforces procedural adherence.
Skilled Quality Systems Manager with broad experience in implementing and managing quality control systems. Strong background in designing procedures that increase efficiency, reduce waste, and enhance product quality. Demonstrated ability to lead teams towards continuous improvement goals while maintaining compliance with industry standards and regulations. Notable impact includes streamlining processes and driving operational excellence in previous roles.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Quality Systems Manager
MEDInstill LLC
New Milford, CT
06.2022 - Current
- Developed and initiated implementation for ISO compliant quality system
- Developed and improved all policies and procedures, which improved effectiveness of quality systems
- Conducted failure mode effects analysis (FMEA) and developed control plans and flowcharts for production processes in all departments
- Worked closely with government representatives and company management on changes and adherence to government regulatory standards
- Performed quality systems audits on all production and engineering products and processes
- Prepared and conducted small-group and large group training sessions
- Insured proper flow down and execution of various quality and specification requirements.
Quality and Regulatory Affairs Manager
Parker Medical Inc.
Danbury, CT
10.2020 - 04.2022
- Performed and documented quality control checks to maintain compliance with company initiatives
- Represented company in medical industry during communications with global regulatory agencies
- Assisted with regulatory product compliance initiatives such as RoHS, REACH, Waste Management, Export Administration Regulations, and UL
- Instituted quality standards and procedures to minimize errors and maximize customer satisfaction
- Updated quality control standards, methods, and procedures to meet compliance requirements
- Minimized costs and maximized returns resulting in $200,000+ savings
- Evaluated quality problems and performed assessments to identify and resolve issues
- Mentored and encouraged employees to strive for excellence while fostering professional growth
- Equipped and organized facility to comply with company strategy for online and offline quality controls
- Wrote and implemented new rework procedures to standardize processes and streamline workflow
- Improved quality processes for increased efficiency and effectiveness
- Mapped process activities to identify shortfalls and propose options to rectify operational inefficiencies
- Developed Key Performance Metrics derived from raw company data to track improvements in organizational efficiency
- Offered friendly and efficient service to customers, handled challenging situations with ease
- Improved operations through consistent hard work and dedication
- Used critical thinking to break down problems, evaluate solutions and make decisions
- Created workflow diagrams and Gantt charts to clearly demonstrate processes and timelines
- Collaborated closely with upper management to drive strategy through development and implementation of new processes
- Researched and selected new ERP system based on business vision, growth, productivity, and customer requirements
- Worked closely with management teams to plan, develop, coordinate, and execute new ERP system implementation strategies aligned to with business vision, mission, and purpose
- Interviewed, hired, trained, and mentored staff by coaching daily, leading performance reviews and offering constructive feedback
- Coordinated Quality Business System Management, Engineering, and ERP projects with defined scope, and managed milestones.
Quality Engineer
Polamer Precision LLC
New Britain, CT
05.2019 - 10.2020
- Responsible for review and disposition of MRB Inventory Accordingly
- Successfully coordinated and led root cause analysis meetings to determine core reason for failures and errors
- Collect and analyze critical process data for continuous improvement
- Revamped Quality MRM Template for more effective meetings and goals
- Expanded risk management measures through spot-checking and increased randomization of inspections (AQL)
- Utilized knowledge of AS900 standards to develop action plan for company certification.
Quality Engineer
New England Airfoils Inc
Farmington, CT
06.2018 - 05.2019
- Successfully led company through AS9100 re-certification, which was granted in first attempt with no major and minor findings
- Prepared and directed company through two customer assessment of Quality Management System for approval as new Supplier
- Constructed and implemented non-conformance process to track daily failures and scrap vs total daily production
- Conducted GAP analysis of Quality Management System to understand its constraints and developed action plan to drive solutions
- Responsible for review and approval of Certification of Compliance of products
- Led, assessed, and tracked supplier's performance
- Facilitated multiple teams during root cause analysis of internal failures and customer reported failures (SCARs)
- Reviewed design drawings, specifications, and customer requirements for new product launch.
Manufacturing Supervisor
Global Steering Systems LLC
Watertown, CT
03.2018 - 06.2018
- Supervise 45+ people, daily set-ups, and start-ups of production equipment
- Drove process development, lean culture and worked with all support functions to improve material flow
- Insured strict compliance with corporate EH&S goals and compliance objectives
- Integrated and developed team on quality mindset and GMP
- Utilized lean concepts to drive process improvements, data analysis and regular project management
- Analyze Overall Equipment Effectiveness (OEE) data to attain solutions and drive improvements
- Monitored daily and weekly key performance indicators to maintain on-track status
- Cultivated professional working relationships with peers and supervisors
- Kept accurate and detailed records of personnel progress and productivity
- Reviewed and assessed ongoing operations, developing initiatives for continuous process improvement
- Located and resolved problems with team production and performance to maintain consistent quality levels
- Collaborated with other leaders and executives to direct workflow and support operations
- Analyzed equipment breakdowns using various troubleshooting methods
- Coordinated schedules and reviewed work performance for staff
- Trained staff of direct labor employees to perform assembly and manufacture of specified products
- Set and enforced performance-oriented production approach, significantly increasing worker output, and reducing safety incidents.
Senior Quality Technician
Global Steering Systems LLC
Watertown, CT
06.2016 - 03.2018
- Effectively improved two key Customers' scorecard in less than one year
- Led / participated in customer meetings and visited customer plants to resolve quality issues and strengthen customer relationship
- Led continual improvement projects that target elimination of waste and enhancement of overall quality system to reduce internal defects and external customer complaints
- Coordinated and led teams through corrective actions activities using root cause analysis methodologies as well as verified robustness of corrective actions
- Successfully reduced scrap cost by 81.25% in key process
- Conducted layer product audits per audit schedule
- Performed Internal Audits of Standard Operation Procedures
- Analyzed Overall Equipment Effectiveness (OEE) data and KPIs to develop action plans for improvement
- Heavily involved in APQP process for new product launch and critical changes; reviewed and updated DFMEA, PFMEA, control plans, work instructions, and other quality system documentation
- Led team through Production Part Approval Process (PPAP)
- Coordinated and conducted safe launch, inspections, testing and analysis to ensure quality of product
- Planned, performed, and monitored MSA, SPC, and capability studies using applications of statistical tools.
Business Systems Manager
Technical Industries Inc.
Torrington, CT
08.2013 - 06.2016
- Coordinated Business Evaluation Meetings and recorded meeting minutes
- Assisted ISO Team Leaders and Internal Auditors and formulated reports on status of quality management system
- Managed cost-efficient quality system improvements
- Developed and maintained long-term relationships with clients, fostering strong service bonds and encouraging return patronage
- Coordinated support responses to customer issues, verifying closure of concerns and correction of deficiencies
- Coordinated with management teams to plan, develop, align and execute strategies that would meet client's vision, mission and purpose
- Tracked corrective action reports and confirmed closure of corrective action requests to demonstrate adherence to quality standards
- Updated quality control standards, methods, and procedures to meet compliance requirements
- Managed and archived quality documentation and participated in internal and external quality audits
- Led critical quality-assurance projects and enhanced productivity, realizing 20% increase in profits
- Liaised with HR manager to organize and perform quality standard training for new and existing staff
- Developed and deployed production control plans and created work instructions and procedures.
Education
Associate of Applied Science: Engineering Technology Pathway -
Naugatuck Valley Community College
Waterbury, CTSkills
- Six Sigma Green Belt
- Risk Analysis (FMEA, SWOT)
- Statistical Analysis Tools (SPC, Capability Study, Minitab)
- Root Cause Analysis Tools (8D Methodology, 3 Legged 5 why's, Is/is Not, Ishikawa)
- Lean Manufacturing (Value Stream Mapping, SIPOC, 6S, Poke Yoke, 7 Wastes, Kaizen, Kanban)
- Process Flow Diagram
- Blueprint Reading
- Total Quality Management
- Quality Audit Management (ISO 9001:2015, IATF 16949:2016, AS9100)
- Federal Drug Administration Regulations
- Regulatory Policies
- International Regulations
- Global Regulatory Compliance
- Risk management
- Operational Planning and Monitoring
- Standard Operating Procedures
- Staff training and development
- Good Manufacturing Practices (GMP)
- Problem Anticipation and Resolution
- Enterprise Resource Planning
- Project Management
- Risk Mitigation
- Quality Management Systems
- Team Training
- Mastery of quality processes
- Regulatory Compliance
- Supplier Relationship Management
- Problem-solving abilities
- Operational Improvements
- Quality processes
- Analytical mindset
Certification
- APICS CPIM
- ISO 9001:2015/ AS9100/ IATF16949 Lead Internal Auditor
- Six Sigma Green Belt
- Project Management
- Lean Manufacturing
- Total Quality Management System
- IPC Modules
- Advanced GD&T
Languages
- Portuguese
- Italian
- Spanish
Timeline
Quality Systems Manager
MEDInstill LLC
06.2022 - Current
Quality and Regulatory Affairs Manager
Parker Medical Inc.
10.2020 - 04.2022
Quality Engineer
Polamer Precision LLC
05.2019 - 10.2020
Quality Engineer
New England Airfoils Inc
06.2018 - 05.2019
Manufacturing Supervisor
Global Steering Systems LLC
03.2018 - 06.2018
Senior Quality Technician
Global Steering Systems LLC
06.2016 - 03.2018
Business Systems Manager
Technical Industries Inc.
08.2013 - 06.2016
Associate of Applied Science: Engineering Technology Pathway -
Naugatuck Valley Community College