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Become A Quality Systems Specialist

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Working As A Quality Systems Specialist

  • Interacting With Computers
  • Communicating with Supervisors, Peers, or Subordinates
  • Getting Information
  • Processing Information
  • Documenting/Recording Information
  • Deal with People

  • Mostly Sitting

  • Repetitive

  • $68,218

    Average Salary

What Does A Quality Systems Specialist Do At Thermo Fisher Scientific

* Apply quality systems knowledge help investigate and close quality issues in various subsystems, such as NCRs, Deviations, and CAPAs
* Develop and assist in quality planning and implementation of process improvements related to equipment – IQOQPQ, validation plans, calibration and preventive maintenance
* Responsible for determining non-conforming products and materials disposition (implementing QA quarantines and/or release of affected inventory)
* Assist in monitoring customer feedback to assess complaints, including assisting in the determination of reportability to regulatory authorities
* Monitor and maintain Quality Management System to ensure compliance with ISO 13485:2016, 21 CFR 820, and other applicable standards/regulations.
* This may include updating established quality procedures and policies
* Interact and assist other groups in relation to quality processes
* Participate in internal and external quality audits
* Essential Functions:
* Support the quality management system by analyzing and closing out subsystem processes
* Apply knowledge of quality systems to help improve compliance throughout organization
* Contacts and Relations:
* Regular contact and interaction with all levels of the organization
* Daily interaction will occur with technical product owners and manufacturing personnel
* Accountability:
* All QA personnel are expected to maintain the confidentiality of sensitive laboratory information including testing data
* Maintain a cooperative and professional relationship with other laboratory staff and departments

What Does A Quality Systems Specialist Do At The Boeing Company

* Duties include, but are not limited to:
* Assists in review of proposals, contracts, regulatory, program and customer requirements to prepare quality assurance plans and tests for hardware and software products, processes and services
* Maintains Quality directives, policies, processes, procedures and metrics to assure program, contract, customer, regulatory requirements, international standards and working agreements are deployed using established procedures
* Collects and verifies data to support the identification of root cause routine problems
* Provides ideas and concepts for corrective action development
* Supports quality source selection and process reviews of suppliers' ability to meet program quality requirements
* Assists with hardware, software and system level audits to determine compliance with quality management system standards, configuration assurance, related business, regulatory and customer requirements
* Documents audit results in standard formats
* Compiles data and provides recommendations for material review disposition
* Works under general supervision

What Does A Quality Systems Specialist Do At System One Services

* ensuring site compliance with regulatory requirements in our GMP and ISO/IEC 17025 environment. -promote quality achievement and performance improvement
* Manage new project/product execution for Quality related functions
* Ensure compliance to applicable regulations (cGMP, ISO/IEC 17025, OSHA)
* Develop and perform cGMP and ISO/IEC 17025 training
* Hire, train and coach Quality personnel
* Manage the document and record control process
* Perform record review and finished product release process
* Support the process for execution, investigation and documentation for deviations, OOS, complaints and non-conformances
* Lead the overall CAPA program to include investigation, root cause analysis, corrective and preventative actions and documentation
* Conduct internal audits; determine and execute the corrective actions
* Conduct customer/ regulatory audits; determine and implement effective corrective actions
* Write and implement required SOP’s and work instructions
* Identify and implement continuous improvement ideas
* Maintain database as needed to support the Quality Management System (QMS

What Does A Quality Systems Specialist Do At Kelly Services

* The Quality Systems Specialist will provide quality systems guidance and support to the Complaint Handling process.
* This role will collaborate with representatives from other functional areas to facilitate timely and accurate Manufacturing Investigations and Device History Reviews.
* The Quality Systems Specialist will perform all manners of Document Control activities, including, but not limited to:
* maintaining Device Master Record files (product drawings, process sheets, inspections sheets, etc.); processing manufacturing changes (MC) by checking MCs for accuracy, assigning change numbers, distributing documents for drafting and release; coordinating change order activities; proofreading and auditing documents for style, grammar, spelling, format and impact it may have on other documentation; providing assistance to change originators in the change control process and system tools.
* He or she will coordinate document scheduling with Manufacturing Engineering to ensure timely production of products and timely product launches.
* He or she will conduct department meetings to discuss quality issues, improvements, workload, issues and concerns, as required.
* He or she may provide feedback to the Supervisor on Performance reviews.
* The Quality Systems Specialist will perform filing and support the imaging/verification process for Quality System Records.
* He or she will perform other related duties and special projects, as required

What Does A Quality Systems Specialist Do At Medtronic

* Ensures Quality System conforms to the Quality System Regulations (QSR), ISO 13485, MDD, CMDR, PAL, corporate and sector requirements.
* Assists with the implementation of Quality System Improvements in conjunction with Quality System Manager and Director of Quality.
* Prepares and completes of Document Change Orders including training as requested.
* Manages the system for implementing changes to Quality System procedures based on the implementation of Sector SOP and Corporate Policy changes.
* Plans, coordinates, and presents Quality System training and/or new employee quality system orientation training including Complaint Handling Awareness.
* Compiles Quality System trend data, prepares presentation of the data at Quality Review Meetings and coordinates Quality Review and Quality Management Review meetings.
* Prepares monthly sector metrics for CAPA, Environmental Monitoring and other Quality System processes as requested.
* Creates and maintains Quality System files and databases to ensure information is accessible and accurate (ex.
* CAPA Tracking Log).
* Supports and coordinates corporate, internal, and external regulatory agency audit activities as assigned.
* Monitors and tracks the implementation of corrective action/preventive action (CAPA) as result of internal and external audits (FDA, TUV, etc.) and reports progress to management on a routine basis.
* Serves as the CAPA Coordinator, as assigned, providing general guidance of CAPA activities and documentation to assure compliance with CAPA policies and procedures, FDA regulations, ISO 13485, and Medical Device Requirements through the review of CAPA records at each CAPA process phase.
* Participates in CAPA activities such as root cause analysis, corrective action plans and effectiveness verifications.
* Enters and updates data within the CAPA database, providing routine status reports and updates on current CAPA system activities to management on a routine basis.
* Assists with the Product Experience Reporting process activities including submission of MDRs (Medical Device Reporting) and closing of complaint file closures as needed.
* Performs data queries in the Complaint Handling Database to support complaint investigations and management requests.
* Assists with sending out test samples as needed to support routine bio burden testing.
* Assists with post distribution activities such as Product Holds and Field Corrective Actions per procedures.
* Facilitates and supports Recall Review Committee Meetings as required.
* Identifies areas for improvement in Quality System SOPs and Forms and implements changes.
* Works closely with SOP Document Guardians to ensure that changes to procedures are adequately identified to ensure affected procedures and forms accurately reflect the represented process and are in compliance with applicable regulations and standards.
* Demonstrates solid technical proficiency in the application of the Corrective and Preventive Action system, to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources acting as a resource to other sites.
* Applies statistical methods in support of tracking/trending of data and in problem solving related to the development and application of solutions to CAPAs and other quality system activities.
* All activities must be performed in compliance with the Quality System.
* Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
* All other duties as assigned

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Quality Systems Specialist Demographics

Gender

  • Female

    54.8%
  • Male

    43.4%
  • Unknown

    1.9%

Ethnicity

  • White

    75.8%
  • Hispanic or Latino

    13.8%
  • Asian

    8.4%
  • Unknown

    1.2%
  • Black or African American

    0.7%
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Languages Spoken

  • Spanish

    63.6%
  • Japanese

    9.1%
  • French

    6.1%
  • Chinese

    3.0%
  • German

    3.0%
  • Carrier

    3.0%
  • Mandarin

    3.0%
  • Thai

    3.0%
  • Korean

    3.0%
  • Italian

    3.0%
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Quality Systems Specialist

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Quality Systems Specialist Education

Quality Systems Specialist

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Real Quality Systems Specialist Salaries

Job Title Company Location Start Date Salary
QC Systems Specialist II Abbvie Inc. Worcester, MA Sep 11, 2015 $96,400
Principal Quality Systems Specialist Medtronic, Inc. Littleton, MA Jun 01, 2012 $91,666 -
$91,800
Quality System Architecture Specialist/Quality SYS Rohm and Haas Chemicals, LLC, A Subsidiary of The Collegeville, PA May 01, 2014 $91,624 -
$129,756
Quality Systems Specialist-Manager Cummins Inc. Columbus, IN Apr 19, 2016 $91,600 -
$112,800
Quality Assurance System Specialist Fidessa Corp. New York, NY Sep 15, 2010 $86,900
Staff Quality System Specialist (Medical Devices Technology) Becton, Dickinson & Company Franklin Lakes, NJ Aug 15, 2016 $85,000
Quality Systems Architecture Specialist Rohm and Haas Chemicals, LLC, A Subsidiary of The Spring House, PA Dec 23, 2011 $80,448 -
$120,672
Quality Systems Specialist Cell Signaling Technology, Inc. Beverly, MA Sep 17, 2016 $80,000 -
$90,000
Quality System Specialist Bridgestone Americas, Inc. Nashville, TN Apr 01, 2013 $79,740
Quality Systems Specialist The Boeing Company Everett, WA Jul 13, 2012 $78,000 -
$139,000
Quality System Specialist Bridgestone Americas, Inc. Nashville, TN Apr 01, 2012 $77,400
Supplier Quality Systems Specialist The Boeing Company Everett, WA Oct 01, 2012 $76,650 -
$133,000
Quality Systems Specialist II Gilead Sciences, Inc. San Dimas, CA Aug 09, 2016 $72,500 -
$76,000
Quality Systems Specialist II Gilead Sciences, Inc. San Dimas, CA Sep 14, 2016 $72,500 -
$76,000
Quality Systems Specialist Medtronic, Inc. Danvers, MA Aug 23, 2016 $72,000
Quality Systems Specialist Terex Corporation Redmond, WA Apr 09, 2015 $71,709 -
$88,202
Quality Systems Specialist Terex Corporation Redmond, WA Sep 04, 2015 $71,709 -
$88,202
Quality Systems Specialist Medtronic, Inc. Littleton, MA Aug 24, 2015 $67,900 -
$72,000
Quality System Specialist Toshiba International Corporation Houston, TX Aug 30, 2016 $66,955 -
$69,172
Quality Systems Specialist Axiom Materials, Inc. Santa Ana, CA Dec 17, 2014 $66,518
Quality Systems Specialist Toshiba International Corporation Houston, TX Aug 30, 2013 $63,960
Quality Systems Specialist II Nanotherapeutics, Inc. Alachua, FL Sep 11, 2015 $62,315
Quality Systems Specialist-QA Validation, DOC. & Ben Venue Laboratories, Inc. Bedford, OH Nov 22, 2010 $60,507 -
$98,426
Quality Systems Specialist Intercell USA, Inc. Gaithersburg, MD Mar 24, 2011 $60,320
Quality Systems Specialist Cummins Inc. Columbus, IN Sep 05, 2013 $59,000 -
$72,200
Quality Systems Specialist Cummins Inc. Columbus, IN May 09, 2013 $59,000 -
$72,200
Quality Systems Documentation Specialist I Shire Us Manufacturing, Inc. Lexington, MA Jan 09, 2016 $58,926

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Top Skills for A Quality Systems Specialist

QualitySystemQualityProceduresQualityAuditsRegulatoryRequirementsCorrectiveActionISOProcessCapabilityManagementSystemFDASupplierQualityInternalAuditProgramDocumentControlSafetyProcessImprovementCustomerComplaintsManagementReviewQMSContinuousImprovementGMPDevice

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Top Quality Systems Specialist Skills

  1. Quality System
  2. Quality Procedures
  3. Quality Audits
You can check out examples of real life uses of top skills on resumes here:
  • Designed and implemented Quality Systems for manufacturing facility including: Change Control, Investigations, Auditing, and Complaint Handling.
  • Reviewed and validated product non-conformances and disposition type, quality procedures and engineering requirements.
  • Traveled extensively to perform quality audits and report on findings.
  • Review and revise the existing standard operating procedures and process requirements assuring that meet the customer and regulatory requirements.
  • Develop and maintain the Internal and Layered Process Audit processes and report of findings and corrective actions.

Top Quality Systems Specialist Employers

Quality Systems Specialist Videos

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