Quality Systems Manager resume example with 5+ years of experience
Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA94105
:
Professional Summary
Adaptable Quality Manager with a 5-year background in implementing and developing improvement processes through collaboration with cross-functional teams. First-rate computer, analysis, and research skills. Specialties include achieving set targets, generating new strategies and maintaining accurate records. Highly energized, reliable, demonstrating exceptional service and receiving positive feedback from customers, co-workers , supervisors and managers. A friendly and responsible person with 5+ years of experience, for a large distribution company who gained its highest regional client satisfaction scores (98.37%) since my joining of the team.
Skills
Operational improvements
Quality processes
MasterControl
Internal Quality Audits
ISO 9000
Quality Risk Management Planning
Trackwise
Quality Management System Compliance
Continuous Process Improvement
Validation Master Planning
Risk mitigation
Root Cause Analysis
Statistical Process Control Methodology
Performance Reports
Problem-solving abilities
Statistical analysis skills
Familiarity with quality standards
Employee training
Market research experience
Annual reports
FDA law understanding
ISO 13485 & 9001 law understanding
Accounting principles
Debt management
Cost savings options
Team management
MS Office
Problem resolution
Project organization
Business operations
Relationship development
Operational improvement
Supervision
Process improvement
Business administration
Staff Management
Submission preparation
Compliance assurance
Data Gathering
Technical Documentation
Project Management
Data verification
Forms management
Manufacturing Processes
Packaging
ISO standards knowledge
Safety protocols
Risk management assessments
Education
, Expected in 2016 ā āAssociates Degree: - GPA:
Southwest Miami Senior High School, Expected in 2013 ā āHigh School Diploma: - GPA:GPA: 3.8
Keiser UniversityFort Lauderdale, FLExpected in 04/2016 ā āJ.D.:Accounting And Business Management - GPA:
Certifications
Certified Quality Manager (CQM)
Certified Internal Auditor (CIA)
Links
Linkedin.com/in/Jessica-Claire/
Work History
Thermo Fisher Scientific Inc. - Quality Systems Manager Boise, ID, 03/2018 - Current
Inspected inbound and outbound products for compliance with established industry standards, company policies and procedures.
Collaborated with contract representatives and oversaw quality control implementations and reporting.
Developed and deployed production control plans, including creating all related work instructions and procedures.
Evaluated quality problems and performed preventive/corrective action to identify and resolve issues.
Increased customer satisfaction through adherence to all quality standards and customer requirements.
Evaluated suitability of business and technical processes and procedures and recommended improvements to comply with updated operations guidelines.
Maintained quality system documentation and updated specific documents to reflect new audit or test results.
Tracked corrective action reports and confirmed closure of corrective action requests to demonstrate adherence to quality standards.
Participated in targeted customer audit initiatives and produced required documentation to support verifiable results.
Worked with users to maintain accurate quality records and supporting materials to document all quality-related activities.
Advised management of quality audit non-compliance issues to facilitate improved audit compliance rates.
Scheduled and managed internal and supplier-based audits to verify compliance with document control procedures.
Improved quality processes for increased efficiency and effectiveness.
Adhered to all legal, safety and health standards.
Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
Equipped and organized facility to comply with company strategy for online and offline quality controls.
Sorted product and provided expertise on non-conforming product requirements.
Prepared working papers, reports and supporting documentation for audit findings.
Developed and implemented corrective actions to bring business areas in line with standards.
Identified control gaps in processes, procedures and systems through in-depth research and assessment and suggested methods for improvement.
Identified audit risks, prepared budgets and coordinated with management and audit team in preparing related reports.
Facilitated financial and operational audits, working with internal and external managers to communicate recommendations or issues surrounding audits.
Identified management control weaknesses and provided value added suggestions for remediation.
Completed audit papers by thoroughly documenting audit tests and findings.
Managed quality assurance program, including on-site evaluations, internal audits and customer surveys.
Delivered subject matter expertise for internal and external customers on compliance best practices and quality control.
Verified consistency in quality planning, quality control, quality insurance and quality improvement.
Delivered and tracked program training for all associates and supervisors in order to safeguard continuing business relationships.
Maintained professional demeanor by staying calm when addressing unhappy or angry customers.
Analog Devices, Inc. - Regulatory Affairs Intern Raleigh, NC, 07/2015 - 12/2018
Prepared and submitted regulatory file applications and supporting documentation.
Received, researched and resolved consumer inquiries.
Maintained excellent attendance record, consistently arriving to work on time.
Resolved conflicts and negotiated mutually beneficial agreements between parties.
Drove operational improvements which resulted in savings and improved profit margins.
Managed quality assurance program, including on-site evaluations, internal audits and customer surveys.
Monitored social media and online sources for industry trends.
Devoted special emphasis to punctuality and worked to maintain outstanding attendance record, consistently arriving to work ready to start immediately.
Worked diligently to resolve unique and recurring complaints, promoting loyalty and enhancing operations.
Worked with vendors to source diverse materials and items for use during device fabrication processes.
Prepared working papers, reports and supporting documentation for audit findings.
Developed and implemented corrective actions to bring business areas in line with standards.
Crozer-Keystone Health System - Regulatory Affairs Coordinator Upland, PA, 07/2015 - 03/2018
Prepared and maintained document inventory for core dossier preparation in collaboration with .
Prepared and submitted regulatory file applications and supporting documentation.
Implemented regulatory guidance procedures for Medical Devices.
Reviewed data to assess compliance with FDA regulations.
Implemented regulatory guidance procedures for the entire business.
Received, researched and resolved consumer inquiries.
Devoted special emphasis to punctuality and worked to maintain outstanding attendance record, consistently arriving to work ready to start immediately.
Resolved conflicts and negotiated mutually beneficial agreements between parties.
Developed team communications and information for ISO meetings.
Increased customer satisfaction by resolving minimizing risk to the end user and shipping errors.
Worked with all types customers(from retail to wholesaler) to understand needs and provide the best service.
Monitored social media and online sources for industry trends.
Saved $200,000 by implementing cost-saving initiatives that addressed long-standing problems.
Managed quality assurance program, including on-site evaluations, internal audits and customer surveys.
Maintained excellent attendance record, consistently arriving to work on time.
Drove operational improvements which resulted in savings and improved profit margins.
Accomplishments
Used Microsoft Excel to develop inventory tracking spreadsheets.
Resolved product issue through consumer testing.
Supervised team of 10 staff members.
Collaborated with team of 15 in the development of US Ophthalmic LLC obtaining an ISO 13485 Certification.
Increased overall productivity and quality by 65% by implementing training programs designed to increase performance levels.
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