Quality Director Job Description

Quality Director Job Description

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Quality director provides support and facilitate for all activities in the area to be carried out in accordance with the Integrated Management System (KORE, ISO 9001, ISO 14001, ISO 17025, ISO 45001, FSSC 22000, GMP & HACCP and FSMA) and legal requirements.

Quality Director Duties & Responsibilities

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

Sample responsibilities for this position include:

Define and implement improvement projects that will yield new or improved testing methods, practices, processes, clearly defined roles and responsibilities, single taxonomy, tools, systems and metrics
Assist in the promulgation of firm standards, processes and procedures to help insure quality audit and accounting work
Evaluate proposed changes to the manufacturing and supply chain processes, and authorize these changes, if appropriate
Drive identification of process improvement opportunities and provide guidance and oversight to automate processes, implement efficiencies, or execute needed changes
Act as technology advocate for implementing QC tools and systems to optimize quality testing and QC center for excellence
Pre-issuance review of financial statements and audit documentation
Review firm systems and specific engagements in the annual internal inspection
Assist (or lead) in the implementation of new audit and accounting standards
Interface with peer reviewers, PCAOB and other inspectors
Managing product quality related priorities and tasks at the respective contract manufacturers

Quality Director Qualifications

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

Licensing or Certifications for Quality Director

List any licenses or certifications required by the position: ASQ, ISO, 9001, QMS, CQE, ISO14001, IATF, IATF16949, FAA, GFSI

Education for Quality Director

Typically a job would require a certain level of education.

Employers hiring for the quality director job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Education, Nursing, Business, Management, Healthcare, MBA, Chemistry

Skills for Quality Director

Desired skills for quality director include:

Excel
Tools
Auditing
DCAA
DCMA
ISO 9001/SAE AS9100 and ISO 14001/OSHAS 18001 requirements
International
Lean & Six Sigma Principles
Power Point
Processes

Desired experience for quality director includes:

GASB knowledge
Experience with governmental organizations
Experience with PPC audit methodology and practice
Experience with securities broker-dealers, investment partnerships and real estate entities
Leading and monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, change controls and leading product related investigations
Designing, Implementing and improving quality systems to realize the highest quality standards attainable for all activities conducted by the company, supporting Product Quality Review and annual report completion on time and leading training

Quality Director Examples

1

Quality Director Job Description

Job Description Example
Our company is growing rapidly and is looking for a quality director. 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 director
  • Facilitating technology transfer, process scale-up and process improvement protects
  • Building authentic relationships and leading business meetings and audits of critical suppliers and contract manufacturers and maintaining all product related Technical Quality Agreements (TQAs)
  • Leading and assisting in internal audits and regulatory agency inspections
  • Ensure compliance of all respective contract manufacturers to both internal requirements and country specific regulations
  • Highlight any risks associated with maintaining supply of commercial drug products to all markets and offer innovative and effective ways to minimize such risks
  • Collaborate with all contract manufacturers, packagers and testing laboratories to resolve any quality issues and guarantee an uninterrupted supply of drug product to the markets
  • Participate in due diligence activities associated with strategic partnerships or new company acquisitions
  • Contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, packagers and laboratories, as required
  • Maintain quality and regulatory compliance, to ensure that there are no significant regulatory agency citations associated with any company specific GMP activities
  • Understand new regulations and guidelines, as they apply to the company business, and implement systems and procedures to incorporate these new regulations, if appropriate
Qualifications for quality director
  • Extensive knowledge of FASB
  • Experience with not-for-profit organizations and OMB Circular A-133 audits
  • Act as Qualified Person QP
  • Lead the development and execution of enterprise-wide quality improvement programing in the Medicaid line of business
  • Direct and lead cross-functional teams to develop strategies, implement action plans, and oversee ongoing operational execution to meet corporate business goals for Medicaid quality performance metrics
  • Work closely with the behavioral health team to ensure that behavioral health metrics are performing as required and supports the development of improvement initiatives as needed
2

Quality Director Job Description

Job Description Example
Our innovative and growing company is hiring for a quality director. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality director
  • Collaborate with external vendors, health homes, clinics and/or internal departments to capture additional data flow/source, ensure quality improvement project implementation, and implement recommendations to further improve health plan’s healthcare quality metrics
  • Lead and drive all data analytics efforts to identify improvement areas, understand marketplace and member/provider behaviors, research member/provider barriers and validate them within population
  • Oversee the development of predictive models and root-cause analyses, and evaluate program effectiveness for Medicaid related quality performance metrics
  • Lead the application and promotion of basic lean/six sigma principles and/or quality improvement methodology to overall development cycle of quality improvement interventions and management activities
  • Support measure research process for product line related quality/behavioral health metrics or as assigned
  • Serve as primary contact/resource for the product line
  • Maintain up-to-date knowledge and understanding of QARR measure technical specifications and regulatory requirements across the Medicaid, MLTC/FIDA, Behavioral Health and HARP lines of business
  • Interface with regulators and regulatory bodies and insures that all regulatory projects are designed, implemented and evaluated according to requirements
  • Regularly monitor regulatory or government policy/methodology updates and industry news and assess and address potential impact from changes related to the product line
  • Mentor, train, and develop staff to gain necessary knowledge and skill sets to perform job duties and grow for future roles
Qualifications for quality director
  • Knowledge of SAS, R, or other statistical software
  • Must have very good skills to influence with integrity
  • Be results oriented and meet agreed expectations
  • Needs to develop a recognition as a ‘fox’ – somebody people come to for advice, to get a job done, to develop creative change activities and successfully drive implementation of the change
  • Ability to manage multi-faceted change projects
  • Participate in at least one Crash Commission investigation as observer / pert of ECC team
3

Quality Director Job Description

Job Description Example
Our company is looking for a quality director. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality director
  • Maintain quality assurance staff job results by coaching, counseling, and disciplining employees
  • Assist (or better lead) in the implementation of new audit and accounting standards
  • Works with Global Quality team and LO Management to establish a quality evaluation system
  • In collaboration with Global Quality, audits & rates T1 QIP set up and implementation status
  • Trains LO, T1 & T2 and manages training related to QIP
  • Establishes and implements QIP, QATs and QA plans in development & commercialization phase in collaboration with LO Management
  • Manages and supports quality related projects/initiatives at T2 suppliers
  • Segment single point of contact for all quality issues, concerns and improvements
  • Accountable, owns and resolves all quality related issues regardless of where they reside
  • Responsible to coordinate, utilize all resources across all regions, collaborate and communicate with all functions and management
Qualifications for quality director
  • Having worked in Telecom area with Service Delivery exp
  • Line manager or Program Manager experience is preferred
  • 5+ years experience working in transactional system (eCommerce) software testing/development
  • Experience working with social media Facebook, twitter, pintrest is a plus
  • Bachelor's degree in business, software engineering or computer science required
  • Bachelor or above, MBA is preferred
4

Quality Director Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality director. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality director
  • Lead the supplier and manufacturing Approval Process and coordination of prototype, pre-launch, and launch part qualification runs
  • Improve the customer experience regarding initial quality and long term reliability by working with Site QA Leaders and cross functional teams to identify issues, drive to root cause and implement robust corrective actions
  • Ensures compliance with Federal, State and local regulations pertaining to training, GMP, QSR, ISO, CE and associated regulatory agencies through management of internal audit functions
  • Assess current organizational structure in quality
  • Customer Complaint Handling System, CAPA, NCR, and other related activities
  • Work in conjunction with the Global Director of Regulatory to implement a global quality strategy that ensures business unit compliance with all regulatory requirements, utilizing harmonized performance excellence methodologies
  • Manage, investigate, audit, analyse and propose improvements in the Quality Management System
  • Implement, monitor and drive the annual Quality Plan improvement efforts
  • Chair the CAPA meeting as needed, coordinate/manage CAPA efforts and interact with customers (internal and external) on a timely manner and inform the customer periodically of the progress relating to the issued CAPA, conducts and or coordinates complaint investigation
  • Provide Quality Management/Compliance Systems assistance for all facilities
Qualifications for quality director
  • Analysis experience in statistics, data analyses, and/or lean/six sigma/quality improvement methodology
  • Experience and knowledge with HEDIS/QARR/CAHPS, CMS Star Ratings, and Accreditation process
  • Master Black Belt certification is preferred
  • Demonstrated leadership abilities and an expert knowledge of the regulatory issues facing clinical engineering programs throughout North America and the ability to stay current with all requirements
  • Requires significant understanding of all aspects of the clinical engineering field, with emphasis on regulatory compliance
  • Requires knowledge of the inner workings of clinical engineering programs including operational and financial interactions
5

Quality Director Job Description

Job Description Example
Our company is hiring for a quality director. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality director
  • Author, change and update Quality Manual and QA procedures as applicable
  • Provide training on QM system process, including general Quality System and GMP training
  • Maintain up-to-date knowledge of all applicable regulations, guidelines and standards
  • Monitor and trend quality data
  • Record and monitor product and raw material non-conformities
  • Oversees test progress status for area of concerns, including recommendations for changes
  • Overall accountability for all QA deliverables within Retail Applications
  • Acts on behalf of the Director, NSC Quality in multiple assigned leadership roles and in the absence of the director
  • Supports the NSC governance model through regular transparent interfaces with the NNSA customer assuring timely notification and information sharing regarding Manufactured Product Quality
  • Development, approval, and execution of the Manufactured Product Quality strategic plan
Qualifications for quality director
  • Exemplary written and oral communication skills including presentations and comprehensive analysis reporting on technical performance issues
  • Knowledge of quality improvement and performance improvement concepts
  • The ability to develop project measures of success, analyze progress, and evaluate outcomes
  • Strong interpersonal skills to execute and manage activities in a fast-paced environment
  • The ability to apply technology in solving business problems
  • Previous experience Audit (Financial), Financial Statement Preparation and IFRS

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