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Become A Quality Systems Manager

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Working As A Quality Systems Manager

  • Evaluating Information to Determine Compliance with Standards
  • Making Decisions and Solving Problems
  • Interacting With Computers
  • Monitor Processes, Materials, or Surroundings
  • Getting Information
  • Deal with People

  • Make Decisions

  • Repetitive

  • Stressful

  • $100,020

    Average Salary

What Does A Quality Systems Manager Do At Danaher Corporation

* Manage and Develop the Quality Management System – Serving as the local Management Representative.
* Ensures FDA QSR(GMP), ISO 13485, MDD, CMDCAS and/or other national or international standards are continuously met.
* Drive Level II PD for the PCKAM businesses, including the development of metrics, trending, and CM’s related to TTI’s and KPI’s.
* Manage and maintain the CAPA process, supporting CAPA owners with effective planning and execution of CAPA projects.
* Hosts quarterly Management Review meetings, including comprehensive data analysis.
* Develop and implement a comprehensive Internal Audit process to meet ISO, CMDCAS, MDD and all other applicable regulatory standards.
* Ensures the development of new products and subsequent change management is conducted in a manner consistent with 3rd party regulatory requirements.
* Serve as the main interface between the Charlotte facility and regulatory agencies for all matters associated with facility certifications and external audits.
* This role will identify, communicate and implement the key priorities to the organization and exercising judgment to determine sense of urgency for priority.
* Works directly with functional leaders and staff members to identify and proactively address areas for improvement with in the Quality Management System

What Does A Quality Systems Manager Do At Astrazeneca Pharmaceuticals LP

* You will support BPOs in interpretation of medical devices and combination products legislation and guidelines to ensure compliant and efficient processes are employed for the Quality Management System.
* You may work with QA managers at Operations sites to design and co-ordinate the implementation of improved quality related international systems
* You will support combination product and medical device products during the lifecycle in providing expert quality device knowledge (e.g.
* Design Controls, Device Risk Management) ensuring quality management system requirements and regulatory/business expectations are being met.
* You may manage or lead device quality input to global projects to deliver elements of the quality strategy/regulatory compliance strategy.
* You will work collaboratively with sites and CMOs to ensure effective resolution of complex device issues including local management of device related issues

What Does A Quality Systems Manager Do At Hill-Rom

* Ensure the proper functioning and continued effectiveness of Quality System procedures, maintaining compliance with required standards and regulations (e.g.
* ISO 13485, ISO 9001, FDA QSR, MDD, Canadian MDR, etc.).
* Acts as primary Subject Matter Expert on Quality Management Systems for Mortara.
* Leads development and implementation of improvements to the Quality Management System across the organization.
* Provide leadership, direction and training to Quality System procedures.
* Oversees the CAPA program and site Corrective Action Board (CAB).
* Ensures linkages between site-level CAB and corporate Global CAB.
* Ensure proper functioning of corrective and preventive action system and effectiveness of changes implemented.
* Oversees and provides education in quality and quality tools for the organization.
* Primary representative for activities and communications associated with internal, customer and regulatory audits performed at Mortara; ensure resolution of reported non-conformances.
* Maintains the internal audit plan/schedule and coordinates audit activities to ensure company requirements are met.
* Acts as Lead Auditor for internal audits.
* Provides metrics related to quality system processes and quality objectives for Management Review.
* Write, review and approve quality system documents.
* Assist in preparation of annual budget request.
* Performs other duties as requested

What Does A Quality Systems Manager Do At Lear Corporation

* Develop and sustain the Quality Management System in line with the required industry standards, including IATF 16949 AND ISO13485, accreditation requirements and business requirements across the organization through existing and new procedures.
* Regulate, control and improve the quality of all processes throughout the business and the final product.
* Manage the audit program to ensure that all nonconformities raised against certification bodies during audits are effectively corrected and independently verified.
* Embed a culture of continuous improvement throughout the company.
* Lead the team to achieve quality management system targets for customers and business goals.
* Develop the Management Systems strategy and the management arrangements for key milestone, demonstrating solid progress against plan.
* Contribute to new business initiatives and projects.
* Review and communicate the impact on QMS
* Manage all external registration requirements to ensure they are met.
* Update quality documentation and communicate to carry forward lessons learned from quality concerns.
* Ensure that all necessary systems and procedures are in place to satisfy all customer requirements and audits.
* Ensure compliance with QMS.
* Introduce new systems and procedures where appropriate.
* Train others in all aspects of the quality system and application of procedures
* Initiate regular internal and process audits of the QMS
* Verify closure of non-conformities and provide detailed analysis

What Does A Quality Systems Manager Do At Thermo Fisher Scientific

* Manage the CMD QMS to ensure it is suitable, adequate and effective to support all applicable FDA Quality System Regulations, ISO 9001, ISO 13485, and the IVD Regulation.
* Manages annual management review, procedure development, continuous improvement of the QMS, and training of personnel on the quality system processes.
* Coordinate responses to customers’ supplier questionnaires, external audits for ISO registration, as well as FDA inspections.
* Develop new process or capability as needed, e.g., CMD Risk Register, convergence on 123Compliance CAPA System; manage CMD CAPA process.
* Work with CMD Product Quality Manager and Business Unit Quality Leaders to align quality metrics and annual priorities and goals.
* Facilitate quarterly reviews with Business Unit and Division leaders.
* Determine priorities for projects regarding maintenance and improvement of systems; recommends priorities and actions for those controlled by outside resources (such as Corporate IT systems) affecting the CMD quality system.
* Other miscellaneous duties as assigned.
* Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally.
* Our mission is to enable our customers to make the world healthier, cleaner and safer.
* We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity.
* Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
* Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected

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How To Become A Quality Systems Manager

Industrial production managers typically need a bachelor’s degree and several years of related work experience.

Education

Employers prefer managers have at least a bachelor’s degree. While the degree may be in any field, many industrial production managers have a bachelor’s degree in business administration or industrial engineering. Sometimes, production workers with many years of experience take management classes and become a production manager. At large plants, where managers have more oversight responsibilities, employers may look for managers who have a Master's of Business Administration (MBA) or a graduate degree in industrial management.

Work Experience in a Related Occupation

Many industrial production managers begin as production workers and move up through the ranks. They usually advance to a first-line supervisory position before eventually being selected for management. Most earn a college degree in business management or take company-sponsored classes to increase their chances of a promotion.

Production managers who join a firm immediately after graduating from college sometimes work as first-line supervisors before beginning their jobs as production managers.

Some managers begin working at a company directly after college or graduate school. They may spend their first few months in training programs, becoming familiar with the production process, company policies, and safety regulations. In large companies, many also spend short periods of time working in other departments, such as purchasing or accounting, to learn more about the company.

Important Qualities

Interpersonal skills. Industrial production managers must have excellent communication skills so they can work with managers from other departments, as well as with the company’s senior-level management.

Leadership skills. To keep the production process running smoothly, industrial production managers must motivate and direct the employees they manage.

Problem-solving skills. Production managers must be able to identify problems immediately and solve them. For example, if a product has a defect, the manager determines whether it is a onetime problem or the result of the production process.

Time-management skills. To meet production deadlines, managers must carefully manage their employees’ time as well as their own.

Licenses, Certifications, and Registrations

While not required, industrial production managers can earn certifications that show a higher level of competency in quality or management systems. The Association for Operations Management offers a Certified in Production and Inventory Management (CPIM) credential. The American Society for Quality offers credentials in quality control. Both certifications require specific amounts of work experience before applying for the credential, so they are generally not earned before entering the occupation.

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Quality Systems Manager jobs

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Real Quality Systems Manager Salaries

Job Title Company Location Start Date Salary
Manager II, Quality, Information Systems Quality Baxter Healthcare Corporation Westlake Village, CA Mar 09, 2015 $174,174
Manager II, Quality, Information Systems Quality Baxter Healthcare Corporation Westlake Village, CA Mar 10, 2014 $156,000
Project Quality Systems Manager Foster Wheeler USA Corporation Houston, TX Feb 22, 2016 $151,653 -
$170,000
Manager, Quality and Management Systems Conocophillips Company Houston, TX Aug 21, 2010 $148,512 -
$190,000
Quality Systems Manager Schlumberger Technology Corporation Sugar Land, TX Sep 21, 2015 $146,474
Manager, Systems Quality Lab126 Cupertino, CA Mar 12, 2012 $140,000
Manager, Quality Systems Foster Wheeler USA Corporation Houston, TX Aug 17, 2015 $138,000
QA Systems, Manager Compliance Gilead Sciences, Inc. Foster City, CA Sep 15, 2010 $138,000
Quality Systems Manager Varian Medical Systems, Inc. Palo Alto, CA Jan 05, 2010 $134,048
Manager, Quality Systems Foster Wheeler USA Corporation Houston, TX Aug 15, 2015 $133,900
Quality Systems Manager Schlumberger Technology Corporation Sugar Land, TX Feb 01, 2013 $127,920
Quality Systems Manager Metropolitan Specialty Labs, Inc. New York, NY Aug 23, 2016 $116,230
Quality Systems Manager Metropolitan Specialty Labs, Inc. New York, NY Oct 24, 2016 $116,230
Quality Management System, Hardware Quality Manager Sonos, Inc. Santa Barbara, CA Oct 09, 2016 $116,168 -
$130,000
Quality Systems Manager Schlumberger Technology Corporation Sugar Land, TX Jan 21, 2013 $113,750
Quality Systems Manager Paddock Laboratories LLC Minneapolis, MN Aug 15, 2011 $110,000
Quality Systems Manager Paddock Laboratories, Inc. Minneapolis, MN Jan 04, 2011 $110,000
Quality Systems Manager Green Mountain Coffee Roasters, Inc. Wakefield, MA Oct 18, 2013 $106,200 -
$118,200
Quality System Manager Ben Venue Laboratories, Inc. Bedford, OH Jun 26, 2013 $103,802 -
$129,753
Manager, Quality Systems Foster Wheeler USA Corporation Houston, TX Sep 19, 2014 $98,000 -
$153,000
Manager, Quality Systems Stryker Corporation Portage, MI Feb 09, 2015 $97,335
Manager, PDP Quality and Quality Systems Deere & Company Waterloo, IA Aug 15, 2013 $96,000 -
$106,000
Quality Systems Manager, Distribution Operations Fresenius USA Manufacturing, Inc. A Fresenius Med Coppell, TX Aug 27, 2014 $96,000
Regional Quality Systems Manager Benteler Automotive Corporation Auburn Hills, MI Aug 27, 2016 $95,000
Manager, Quality Systems, Clinical Analysis Group Tenet Empployment Inc. Dallas, TX Dec 10, 2014 $92,500
Manager-Zeeland Global Quality Systems Mead Johnson & Company, LLC Zeeland, MI Sep 01, 2013 $92,000
Business Development and Quality Management System Manager 7 Layers, Inc. Irvine, CA Jun 09, 2016 $91,927

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Top Skills for A Quality Systems Manager

Iso/TsEnsureComplianceProceduresInternalQualityAuditsSupplierQualityCustomerComplaintsQualityManagementSystemInternalAuditProgramCorrectiveActionRegulatoryRequirementsSafetyProgramCapaFDADocumentControlContinuousImprovementSigmaManagementReviewProcessImprovementMedicalDeviceSPC

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Top Quality Systems Manager Skills

  1. Iso/Ts
  2. Ensure Compliance
  3. Procedures
You can check out examples of real life uses of top skills on resumes here:
  • Achieved successful transition of 23 manufacturing and 6 supporting sites from QS9000 to ISO/TS16949.
  • Maintained and administered the Quality Systems to ensure compliance with ISO 9001-2008 at two facilities.
  • Designed layout and product selection for Company catalog, Coordinated and implemented ISO Quality System procedures.
  • Perform internal quality audits and Dock audits as directed.
  • Negotiated with individual suppliers exceptions to the Supplier Quality Program.

Top Quality Systems Manager Employers

Quality Systems Manager Videos

The Ingredients of Quality Management

A Day in the Life - Health Services Manager

Career Advice on becoming a Health and Safety Manager by Hamish B (Full Version)

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