Quality Management System Job Description

Quality Management System Job Description

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Quality management system provides support and maintains compliance with all company guidelines, union contracts, IATF 16949, ISO 9001 and all applicable government regulations and standards.

Quality Management System Duties & Responsibilities

To write an effective quality management system job description, begin by listing detailed duties, responsibilities and expectations. We have included quality management system job description templates that you can modify and use.

Sample responsibilities for this position include:

Lead a process approach based internal audits in North America locations
Liaise with external calibration service providers
Lead periodic Global QMS meeting, coordinate with Global QMS contacts and manage Global QMS dashboard
Plans, schedules, directs evaluates, and manages the complex day-to-day work of the DMS services staff
Responsible for attaining DMS key performance indicators (KPI), process improvements and ensures that the DMS results fulfill the Quality department's overall mission statement
Accountable for the issuance and maintenance of controlled documents for the Fremont site, to ensure correct implementation, access, and upkeep of documents
Initiate workflows upon receipt of revision requests for all controlled document types (SOPs, forms, Quality Standards)
Assist as necessary to maintain filing system for but not limited to daily systems release reports, temperature charts, cleaning logs, equipment log books
Assist with preparing aseptic fill records and associated sampling documents/labels, packaging records, solution records, and other production records per the production schedule(s)
Performs all Company business in accordance with all regulations (e.g., EEO, FDA, ) and Company policy and procedures

Quality Management System Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Quality Management System

List any licenses or certifications required by the position: ISO, 9001, QMS, IRIS, ASQ, AS9100, ISO9001, RI, WP, ACA

Education for Quality Management System

Typically a job would require a certain level of education.

Employers hiring for the quality management system job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Engineering, Education, Business, Science, Technical, Nursing, Management, Manufacturing, Computer Science, Administration

Skills for Quality Management System

Desired skills for quality management system include:

CMS CoP requirements
Hospital operations
Systems and processes
ISO 9001
IATF 16949
Outlook
Change control
Document management and training as it pertains to a GMP environment
Excel

Desired experience for quality management system includes:

Honest, open minded, candid, high personal Integrity
Experience and knowledge in a broad range of quality best practices and industry codes and standards
State Award or National Baldrige Award examiner experience
Good understanding and working knowledge on Tools like Statistical methods, Sampling, SPC, FMEA, and MSA
Exposure to construction quality standards and implementation.*LI-TJ
Preference will be given to those with advanced working knowledge of industrial systems and related operational controls, monitoring systems, and/or third (3rd) party audit experience

Quality Management System Examples

1

Quality Management System Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality management system. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality management system
  • Assist as necessary to maintain filing system/training database
  • Position shall develop and routinely provide metrics to measure the suitability and effectiveness of various Quality Systems product performance
  • Position is responsible for producing, collecting, and presenting metrics to various functions, internal and external customers, Management Review, and Post Market Surveillance
  • Respond to internal and external requests for information by preparing and analyzing ad-hoc queries and reports
  • Must have the ability to work with multiple software programs and tools
  • Position will be an audit facing subject matter expert
  • Must have experience working in a FDA regulated environment, preferably Medical Device and IVDD
  • Own the quality system audits and documentation system
  • Complete quality internal audits and coordinate representation of external audits
  • Maintain open items log and confirm nonconformances are closed
Qualifications for quality management system
  • Requires a Bachelor’s degree from an accredited institution with four plus (4+) years of professional experience with Controlled Documents (SOPs, manufacturing and testing specifications, validation documents, and/or document version control experience, with a minimum of two (2) years’ experience managing/directing people/teams in a GMP Pharmaceutical manufacturing environment
  • In lieu of a Bachelor's degree, will consider an Associate's degree from an accredited institution, in a related field with a minimum eight (8) years’ experience with Controlled Documents (SOPs, manufacturing and testing specifications, validation documents, and/or document version control experience, with four plus (4+) years’ experience managing/directing people/teams in a GMP Pharmaceutical manufacturing environment
  • In lieu of a Bachelor's or Associate's degree, will consider a High school diploma/GED with over ten (10) years’ experience with Controlled Documents (SOPs, manufacturing and testing specifications, Validation documents, and/or document version control experience with six (6) years’ experience managing/directing people/teams plus in a GMP in a Pharmaceutical manufacturing environment
  • Demonstrates knowledge in Document Management principles and systems relating to DMS, and being a LMSO and IDEA for CON systems
  • Demonstrates success in project execution with involvement in multiple major projects
  • Demonstrated ability to participate effectively in and lead a team environment, including cross-functional teams
2

Quality Management System Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of quality management system. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality management system
  • Coordinate the review and approval of GxP documents in the electronic document management system
  • Provide expertise to document originators, ensuring documents are created/edited per current procedures
  • Monitor, reconcile and audit approved documents, ensuring all compliance requirements for format, content, standardization and periodic review
  • Ensure that customer expectations are met for the quality of the final GxP document and its implementation schedule
  • Liaise with training department to ensure document effective date does not result in adverse impact to trainees or training metrics
  • Provide oversight/support of periodic document review process, and will run Periodic Document Review Cognos reports for Virtual Organizations and send notifications to group owners and document authors to drive timely completions
  • Assist with reporting and analysis of biannual JSC Global Periodic Document Review metrics
  • Serve as an electronic document management system (EDMS) super user and train new associates or document owners in document management processes and the related EDMS
  • Maintain key elements of the QMS Customer complaint resolution, Root Cause Analysis, Corrective and Preventive action, Internal Audit protocol, Management Review
  • Defines the process application assessment plan
Qualifications for quality management system
  • Ability to interpret and relate Quality standards for implementation and review to functional areas
  • Requires strong leader, influential and collaborative skills and organizational skills
  • Strong staff coaching and development skills
  • Strong ability to set vision and direction, set expectations and motivate
  • Performance focused, persistent, sound decision-making, open minded, innovative/creative and results oriented
  • Ability to work effectively on problems of diverse scope, with analysis/evaluation of data
3

Quality Management System Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality management system. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality management system
  • Perform under the general direction of the Director of Quality Assurance in accordance with standard practices and ISO/cGMP regulations
  • Coordinate completion of supplier audits including managing the audit schedule for both on-site and postal audits, administrating and tracking postal audits, maintain archive of all audit reports, and maintain Approved Supplier List per effective controlled procedure
  • Contributor to the administration of Engineering Change Order Process
  • Assist in Maintaining KPI metrics for Quality Assurance activities
  • Draw up regular activity reports
  • Ensure quality of procedure writing
  • Consistent application of Quality system standards to multiple IT Quality system areas
  • Develops solutions to routine assigned activities of moderate/high scope & complexity
  • Follows applicable Company / Unit procedures and may make updates to IT systems including validation and also for IT systems associated procedures and policies
  • Works within and across functions for assigned IT Quality systems
Qualifications for quality management system
  • High level of personal motivation and initiative, and ability to work independently on projects
  • May participate in BI interactions with various governmental agencies/regulators and external auditors
  • Manage department Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to quality testing
  • Work is primarily directed at the site
  • May be required to travel nationally
  • Requires physical activity such as almost constant standing, walking, eyestrain
4

Quality Management System Job Description

Job Description Example
Our growing company is looking for a quality management system. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality management system
  • Preparation of quality and environmental reports for management review
  • Participation in internal and external Q&E MS audits
  • Other ad hoc coordination and admin activities as support to Document Control and maintenance of information on the Intranet
  • Lead, facilitate and mentor individuals/teams/committees to assure the successful organization and execution of processes to achieve quality outcomes, patient safety and ongoing accreditation readiness
  • Develop and maintain relationships at campus, functional, and system levels
  • Direct and support quality program continual process improvement of campus and system initiatives
  • Work in cooperation with campus Leadership (e.g., Chief Executive, Nurse Executive, Vice President of Medical Affairs and managers/directors) and system Leadership (VP Quality, COO)
  • Oversee required reporting to the system-wide quality management oversight body
  • Provide campus caregivers and core leaders with training/coaching/mentoring on quality and continual process improvement concepts
  • Ensure aligned, standardized processes, procedures, nomenclature and terminology within the assigned campus, consistent with system standards
Qualifications for quality management system
  • The schedule is dependent on the shift for which the associate is hired
  • Attendance requirements are based on general attendance policies
  • Document Management principles and systems relating to DMS, LMSO and IDEA for CON systems
  • Minimum of high school education with three (3) years relevant experience OR Associates degree, from an accredited institution, with more than one (1) year relevant experience
  • Experience to include documentation systems and Quality assurance requirements
  • This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications
5

Quality Management System Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality management system. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality management system
  • Establish, implement, and support the development of hospital specific metrics for monitoring hospital and system effectiveness
  • Research, draft, and prepare standards for committee review and approval
  • Manages the CAIR and client survey processes, suggests improvements to the client experience
  • Facilitates CAIR meetings, participates in RCAs and critique CAPAs letters for completeness prior to sending to the client
  • Perform analysis of departmental and sponsor metrics, identify trends and suggest actions to improve the data
  • Facilitates discussions and drives improvements with operational departments following client survey feedback
  • Develop training material and train Process Owners to develop robust CAPA plans and effectiveness checks.These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties
  • Collects, analyzes and trends client satisfaction metrics data
  • Identifies and implements improvement opportunities for Issue Management processes
  • Primary Quality representation for compliance with ATEX, IECEx, FM
Qualifications for quality management system
  • Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting
  • Minimum of 5 years managing and leading the IS/IT quality management system and associated teams at the company or corporate level
  • Assist in analyzing, researching, and documenting new and existing quality operations processes systemic needs to support business processes
  • Creation of basic design specifications including both form and workflow documentation, ensuring business requirements are met
  • Develop and deliver training on processes in person and on the phone in order to implement existing QMS modules in other business units and regions
  • Research, test, and troubleshoot issues related to Quality Management System processes answer questions from users

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