InforCloudsuite
Nichole Thompson
Trevor,WI
Summary
Quality and Management System Professional with more than 10 years of experience in both the medical device and food packaging industry. With experience in: Regulatory Affairs, Regulatory Standards ( ISO, GMP, SQF, BRC, FSSC 22000), Training (ISO 9001:2016 Certified Trainer), , Quality Management, Quality Assurance, Supervision, Data Analysis, Procedural Writing, Quality Management Systems Development, Auditing (Internal, External, Laboratory, Food Processing), Developing KPIs, Statistical Process Control, Food Safety Management Systems and HACCP (Hazard Analysis Critical Control Point) programs.
Overview
10
10
years of professional experience
4
4
Certification
Work History
Quality Manager
Vonco Products
03.2022 - Current
- Increased efficiency of the QMS by regularly reviewing procedures and making updates based on changing business needs or industry advancements.
- Managed root cause analysis investigations, determining underlying issues in product failures and implementing corrective actions as necessary.
- Enhanced regulatory compliance by developing and implementing robust policies and procedures.
- Conducted thorough audits to ensure adherence to industry standards and regulatory requirements, maintaining compliance consistently.
- Promoted a proactive approach to risk management within the organization, mitigating potential concerns before they escalated into larger issues.
- Mentored and encouraged employees to strive for excellence while fostering professional growth.
- Implemented change control systems for efficient tracking and management of document revisions related to regulatory submissions.
- Enhanced regulatory compliance by developing and implementing effective policies and procedures.
- Conducted thorough audits to identify areas of improvement, leading to strengthened internal controls.
- Oversaw timely preparation and submission of high-quality documentation for product registrations and renewals.
- Assisted in preparation of high-quality submissions for FDA approval, leading to faster market entry for products.
- Reviewed advertising materials before release to verify claims were supported by scientific evidence, minimizing potential legal risks.
- Prepared and submitted regulatory file applications and supporting documentation.
- Complete annual FDA Establishment registrations for facility and complete protocols of Analysis for shipments as required by specific regulations
- Complete Annual ISO 13485:2016 and AIB food safety facility audits
Didion Milling
Quality Control Lab Supervisor
06.2019 - 09.2021
- Investigated and identified quality issues to uncover root causes and explore potential corrective actions.
- Inspected production areas regularly to identify and process violations impacting final quality results.
- Highlighted compliance issues for management team.
- Identified internal and external issues within the organizations in accordance with the FSSC 22000 standard
- Trained select employees on FSSC 22000 Standard Requirements
- Drafted overall system procedures and Standard Operating Procedures (SOPs)
- Developed systems to control externally provided products and services
- Trained key employees on conducting internal Quality Audits to establish a Continuous Improvements
- Maintained high precision standards by regularly calibrating measuring instruments and verifying part accuracy throughout the production process.
- Improved product quality by consistently monitoring tolerances and adjusting testing protocols as needed.
- Completed Annual FSSC 2200 food safety audit
Quality Manager
MaxUS Operations
06.2019 - 09.2021
- Auditing of Quality and Management Systems
- Establishing Quality Control and Management Systems to ISO 9001:2015 and SQF food safety standards
- Identified quality problems and recommended solutions.
- Analyzed issues and recommended corrective actions to improve final results.
- Increased efficiency of the QMS by regularly reviewing procedures and making updates based on changing business needs or industry advancements.
- Improved product quality by implementing stringent inspection processes and quality control measures.
- Managed root cause analysis investigations, determining underlying issues in product failures and implementing corrective actions as necessary.
- Conducted thorough audits to ensure adherence to industry standards and regulatory requirements, maintaining compliance consistently.
- Evaluated and approved new suppliers based on thorough assessments of their quality management systems, ensuring ongoing reliability in the supply chain.
- Calibrated instruments and scales in production area and quality lab.
- Wrote and implemented new rework procedures to standardize processes and streamline workflow.
- Ensured proper documentation of all activities related to food safety management systems, facilitating smooth audits from external regulatory bodies as needed.
- Enhanced food safety measures by implementing comprehensive risk assessments and mitigation strategies.
- Monitored industry trends and emerging technologies relevant to food safety, keeping the organization at the forefront of best practices and innovation.
- Collaborated with cross-functional teams to develop risk mitigation strategies, reducing potential non-compliance issues.
- Assisted in preparation of high-quality submissions for FDA approval, leading to faster market entry for products.
- Maintained and archived regulatory paperwork.
- Served as PCQI Practitioner
- Complete annual FDA Establishment registrations for facility and complete protocols of Analysis for shipments as required by specific regulations
- Complete Annual ISO 9001:2006 and SQF food safety facility audits
Lead Machine Operator
TS Food Packaging
11.2014 - 02.2016
- Trained new machine operators, ensuring adherence to safety protocols and efficient operation procedures.
- Played a key role in meeting daily production targets consistently by efficiently managing machine operations.
- Reduced machine downtime by promptly troubleshooting and resolving operational issues.
- Conducted root cause analyses on recurring issues, implementing corrective actions that resulted in long-term solutions.
- Collaborated with team members to achieve department goals and maintain high productivity standards.
- Coordinated with quality control teams to address any product defects or discrepancies, ensuring customer satisfaction.
- Implemented process improvements that led to reduced waste and increased output for the production line.
- Evaluated samples against standards by completing measurements, visual inspections, and other established tests.
Education
Bachelor of Science - Human Services Management
University of Phoenix
Phoenix, AZ06.2012
Skills
- Quality Audits
- Management System Audits
- Risk Management
- Inspections
- ISO Standards
- Impact Assessment
- Medical Device Regulations
- Regulatory Policies
- Submission preparation
- Document Control
- HACCP Implementation
- Compliance Monitoring
Certification
- CQM - Certified Quality Manager
- ISO 9001:2015 Lead Auditor-AQS Solutions-DEKRA-2020
- GMPs and HACCP Training Certification- FIC-2019
- PCQI-Preventative Controls for Human Food Certification- 2019
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeWork Location
HybridRemoteOn-SiteImportant To Me
Company CultureWork-life balanceCareer advancementFlexible work hoursPaid time offPersonal development programsQuote
It is never too late to be what you might have been.
George Eliot
Software
Appian
Languages
English
Interests
Camping
Hiking
Bike Riding
Reading
Timeline
Quality Manager
Vonco Products
03.2022 - Current
Didion Milling
Quality Control Lab Supervisor
06.2019 - 09.2021
Quality Manager
MaxUS Operations
06.2019 - 09.2021
Lead Machine Operator
TS Food Packaging
11.2014 - 02.2016
Bachelor of Science - Human Services Management
University of Phoenix
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