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Quality Systems Manager resume example with 5+ years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
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 Associates Degree : - GPA :
Southwest Miami Senior High School , Expected in 2013 High School Diploma : - GPA : GPA: 3.8
Keiser University Fort Lauderdale, FL Expected in 04/2016 J.D. : Accounting And Business Management - GPA :
Certifications
  • Certified Quality Manager (CQM)
  • Certified Internal Auditor (CIA)
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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Resume Overview

School Attended

  • Southwest Miami Senior High School
  • Keiser University

Job Titles Held:

  • Quality Systems Manager
  • Regulatory Affairs Intern
  • Regulatory Affairs Coordinator

Degrees

  • Associates Degree
  • High School Diploma
  • J.D.

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