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Quality systems specialist skills for your resume and career

Updated January 8, 2025
5 min read
Below we've compiled a list of the most critical quality systems specialist skills. We ranked the top skills for quality systems specialists based on the percentage of resumes they appeared on. For example, 9.5% of quality systems specialist resumes contained quality system as a skill. Continue reading to find out what skills a quality systems specialist needs to be successful in the workplace.

15 quality systems specialist skills for your resume and career

1. Quality System

A quality system is an organizational structure that helps management, procedures, and processes. The quality system helps the company to achieve its goals by following the right procedures. The quality system is usually documented and is based around a manual that defines and controls the system.

Here's how quality systems specialists use quality system:
  • Assist manufacturing site with the development and implementation of quality system remediation activities to achieve compliance with all applicable standards.
  • Provided quality system design and analysis review to validate the integrity of quality decisions that affect products and services.

2. FDA

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

Here's how quality systems specialists use fda:
  • Conducted audits of pharmaceutical suppliers evaluating compliance with FDA, customer purchase order and supplier requirements.
  • Performed final review of complaint investigations per company procedure and FDA guidelines.

3. ISO

Here's how quality systems specialists use iso:
  • Maintained ISO 9001 certification for business globally, overseeing audit program and advocating various continuous improvement efforts.
  • Recruited to Quality Specialist position to implement ISO 9001-2000 Certification.

4. Continuous Improvement

Continuous improvement is an ongoing process of improvement of products, services, and processes with the help of innovative ideas. It is an organized approach that helps an organization to find its weaknesses and improve them.

Here's how quality systems specialists use continuous improvement:
  • Design, implement and refine manufacturing process by applying continuous improvement and lean manufacturing principles to all areas of production.
  • Support continuous improvement of products and processes by inspecting the fabrication, lamination and installation of Composite components.

5. GMP

GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.

Here's how quality systems specialists use gmp:
  • Assist Quality Assurance by handling and reviewing documentation associated with GMP regulations.
  • Coordinated and offered GMP training related to Quality Audits to production personnel.

6. Corrective Action

Here's how quality systems specialists use corrective action:
  • Performed corrective/preventive action effectiveness evaluations at appropriate intervals.
  • Interfaced with management to assign corrective action responsibility for audit findings, and aided in implementation of necessary corrective action.

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7. QMS

Here's how quality systems specialists use qms:
  • Lead a cross-functional group of Site Compliance employees to review processes and educate employees on requirements from Regulatory and QMS sources.
  • Represent Quality with the Engineering and Operations to assess risks and facilitate preventive action and QMS improvement.

8. Process Improvement

Here's how quality systems specialists use process improvement:
  • Initiated quarterly process improvement focused assessments, presented recommendations to the authors and quality management, leading to process improvement updates.
  • Generated and maintained statistical measurements and data for trend information as it related to process improvement and audit results.

9. Management Review

Management review refers to a meeting to evaluate a management department to see if they are functioning the desired way. It involves a chairperson who leads the conference and discusses the management team's progress and procedures.

Here's how quality systems specialists use management review:
  • Transferred to CRM and developed and implemented an enterprise-wide Management Review Process that included the implementation of Performance / Balanced Scorecards.
  • Collaborate with the Quality Manager to prepare the Management Review presentation and actively participate in the review meetings.

10. PowerPoint

Here's how quality systems specialists use powerpoint:
  • Prepared PowerPoint presentations, coordinated agenda items, and provided computer support for the monthly Business Excellence Council meetings.
  • Developed and delivered quality training curriculum via PowerPoint presentations for various departments including Supply Chain, Logistics, Production and Engineering.

11. CFR

CFR, or Code of Federal Regulations, is the codification of general and permanent regulations published in the federal register by executive agencies and departments of the government of the federation. Its aim is to present the official and complete text of government regulations in one organized publication and provide a comprehensive reference for anyone who needs to know.

Here's how quality systems specialists use cfr:
  • Developed the design control guideline for KMI/PAREXEL based on the CFR, AAMI and industries practice guidelines.
  • Maintain knowledge of CFR Parts 800-1299, Canadian Code of Regulations, European Council Directive 93/42/EEC.

12. Data Analysis

Here's how quality systems specialists use data analysis:
  • Conduct data analysis for improvement programs and initiatives.
  • Supported team in Design of Experiments, test plans, and data analysis.

13. Customer Complaints

Here's how quality systems specialists use customer complaints:
  • Coordinated and monitored the status of and response to all customer complaints consistent with regulatory and business requirements.
  • Notified Senior Management of atypical trends observed in the customer complaints system.

14. Quality Metrics

Here's how quality systems specialists use quality metrics:
  • Develop Quality Metrics and resolve issues outside acceptable parameters.
  • Prepare and deliver presentations on quality metrics to top management on a monthly basis.

15. Sigma

In Greek alphabets, sigma is the 18th letter that means "to sum up". In statistics, the lower case symbol of sigma is the unit of measurement for standard deviation which is used to assess the variability in a given set of data. While the upper case symbol is for summation notation means to add up all the given numbers in the data set.

Here's how quality systems specialists use sigma:
  • Reduced quality incidents to customers by managing key performance indicators / metrics and championing Six Sigma projects across business.
  • Led Six Sigma specification optimization project focused on corrugated cases for cost reduction.
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List of quality systems specialist skills to add to your resume

Quality systems specialist skills

The most important skills for a quality systems specialist resume and required skills for a quality systems specialist to have include:

  • Quality System
  • FDA
  • ISO
  • Continuous Improvement
  • GMP
  • Corrective Action
  • QMS
  • Process Improvement
  • Management Review
  • PowerPoint
  • CFR
  • Data Analysis
  • Customer Complaints
  • Quality Metrics
  • Sigma
  • Quality Procedures
  • International Standards
  • External Audits
  • Quality Issues
  • SME
  • TrackWise
  • Material Review
  • Preventive Actions
  • Regulatory Agencies
  • Quality Standards
  • Supplier Quality
  • Regulatory Compliance
  • Quality Audits
  • Supplier Audits
  • Lean Six Sigma
  • Audit Findings
  • Process Reviews
  • Product Quality
  • QC
  • Internal Audit
  • SharePoint
  • Audit Reports
  • QSR
  • AS9100
  • Training Programs
  • Program Development
  • MasterControl
  • Lifecycle Management
  • Lean Manufacturing
  • Customer Satisfaction
  • Technical Support
  • Standard Operating Procedure
  • FAA
  • Manage Change

Updated January 8, 2025

Zippia Research Team
Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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