Quality Specialist Job Description

Quality Specialist Job Description

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Quality Specialist Duties & Responsibilities

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

Sample responsibilities for this position include:

Update and maintain the Approved Supplier List and Approved Materials List
Conduct/participate in supplier audits
Support preparation, review, approval and execution (where applicable) of site related documentation (Procedures, Forms, Transfer Strategies / Plans )
Track and trend key quality indicators and issue reports
Read, understand and apply HEDIS/HCC specification and/or policy as it relates to compliance and outreach
Review patient's charts as needed to determine compliance based on specification or process outlined
Determine next steps based on chart review findings
Determine possible root cause to issue effecting patient compliance and present issue and possible solutions to management
Conduct work essential to supporting outreach efforts
Educate providers and other staff on quality-related activities

Quality Specialist Qualifications

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

Licensing or Certifications for Quality Specialist

List any licenses or certifications required by the position: ISO, PQM, ASQ, AS9100, GFSI, WI, IPC, QM, 9001, A&P

Education for Quality Specialist

Typically a job would require a certain level of education.

Employers hiring for the quality specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and High School Degree in Business/Administration, Biological Sciences, Engineering, Science, Technical, Education, Chemistry, Manufacturing, Associates, Supervision

Skills for Quality Specialist

Desired skills for quality specialist include:

Excel
Word
GMP
MS Office
Jenkins
Applicable local
Federal/national statutes and guidelines
State/province
Microsoft Office
Microsoft Excel

Desired experience for quality specialist includes:

Laboratory Analytical function
Previous experience with internal audits and compliance
Organization using established methodology ( Six-sigma)
Post-graduate qualification in Lean/Six sigma
Quality Improvement experience in services, employing
Demonstrate high technical ability and attention to detail to do the job at a high level of accomplishment

Quality Specialist Examples

1

Quality Specialist Job Description

Job Description Example
Our innovative and growing company is looking for a quality specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality specialist
  • Share audit results with management regarding employee performance
  • Maintain performance standard documentation on employees audited in order to provide feedback to the employee's audited
  • Strong analytical skills, pays attention to detail
  • Excellent organizational skills, leadership and communication abilities both verbal and written
  • Evaluating, responding , addressing and closing the PI
  • Maintaining the Back log count and adhering to SLA defined
  • Manage document changes, creations and deletions
  • Support business/function leaders in the creation, development, implementation and training related to document change
  • Support teams throughout document control process to completion as needed
  • Update current quality processes as required
Qualifications for quality specialist
  • Quality function
  • Bachelor’s degree (B.S.) from four-year college or university in Chemistry or closely related field
  • Experience in a quality control laboratory is ideal
  • Ability to be self-driven and capable of working on own initiative part of a team
  • College or University graduate is preferred
  • Minimum of two (2) years’ experience in a quality function with an ISO-based quality system is preferred
2

Quality Specialist Job Description

Job Description Example
Our growing company is looking to fill the role of quality specialist. 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 specialist
  • Lead activities to design/implement improvements to drive timeliness / accuracy metrics in complaint management processes and linked processes
  • Collaborate with other departments to lead or support change / improvement efforts (Customer Support, Product Analysis, Medical Surveillance, Research and Development, Marketing / Sales)
  • Responsible for conducting audits on defects received for metrics and provide consistent feedback to investigators
  • Conduct regular knowledge checks on floor through process tests, huddles, Conduct reviews for other reviewer and drive Calibrations efforts across sites
  • Interface with contract manufacturing organizations, oversight responsibilities include review of batch documentation, deviations, investigations, up to and including product release
  • Provide back-up support to on-going QA operations as needed, review and approval of analytical methods validation and transfer activities
  • Provide QA support for Quality System cross-functional team development activities such as TrackWise enhancements for Change Control, Deviations, Investigations, and Supplier Quality Management
  • Order to support the operations and quality requirements for business operations
  • Provide QA analysis to Training team for individuals/team/site to improving knowledge gaps
  • Keeping updated with relevant regulations and scientific knowledge within the area in Agilent’s quality system
Qualifications for quality specialist
  • Demonstrated experience in applying problem-solving skills to identify problem root causes, resolve process problems and develop / implement opportunities for improvement
  • Demonstrated ability to document process procedures
  • Understanding of statistical analysis and quantitative analysis of data supporting strategy-level decision making
  • Fluent English Speaker, French-speaking an asset
  • Minimum of two (2) years’ experience in conducting internal audits (completed at least 15 full system audits) preferred
  • Minimum of two (2) years’ experience in gathering and reporting KPI data preferred
3

Quality Specialist Job Description

Job Description Example
Our company is looking to fill the role of quality specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality specialist
  • Provide review of quality requirements for completeness and accuracy
  • Develop the sampling plans, based on recognized principles, in order to ensure the quality of the materials used in production
  • Analyze the sources of rejection of parts purchased and support external suppliers with the actions to be implemented to meet requirements
  • Validate the action plans received from suppliers following non-conformances (constant interaction with external suppliers)
  • Keep track of costs related to non-quality caused by suppliers
  • Manage the supplier performance evaluation measurement system
  • Guide suppliers toward reaching requirements and participate in performance reviews with Procurement
  • Establish and execute a plan for supplier quality audits
  • Participate in supplier selection as described in the product development process
  • Ensure that procedures and processes are in place to guarantee the quality of parts and appliances produced
Qualifications for quality specialist
  • Detail-oriented and ability to be flexible and adaptable to changing situations
  • Ability to develop and deliver presentations to Portfolio management and to the external customer
  • Certified ISO 9001 Auditor / ASQ Quality Auditor / ASQ Quality Engineer / ASQ Quality Manager preferred
  • Typically 5+ years of experience and demonstrated success at the highest level of the functional area demonstrated success in a quality role
  • Current knowledge of The Joint Commission, NCQA, federal, state, & local requirements
  • Knowledge in application of adult learning theory in program development
4

Quality Specialist Job Description

Job Description Example
Our company is growing rapidly and is looking for a quality specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality specialist
  • Analyze opportunities for improvement and implement the appropriate action plans
  • Understand, develop, maintain and update the quality management system
  • Understand and be accountable for the operations of all certifications (Rohs, NSF)
  • Share Audit feedback with Investigators/Team managers
  • Provide technical support to manufacturing and R&D as required to assess Quality of finished product
  • Investigate all product quality non-conformances
  • Participates in WCM Quality Pillar initiatives
  • Recommends improvements in process and product Quality at Carpenter to increase First Time Through (FTT)
  • Provides support in the establishment of Critical to Quality measures (CTQ), Key Process Characteristics (KCC), Key Control Characteristics (KCC), control plans and FMEA
  • Identify and recommend improvements in critical work center Overall Equipment Effectiveness (OEE)
Qualifications for quality specialist
  • Effective team player in working with Portfolio staff to improve quality
  • Understanding of ISO procedures
  • A high standard of communication skills, written and verbal
  • Understanding of Total Quality Management
  • A demonstrated knowledge of quality assurance and continuous improvement methods
  • Proven experience of Lean Manufacturing including Six Sigma methodology (Black Belt level)
5

Quality Specialist Job Description

Job Description Example
Our growing company is looking for a quality specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality specialist
  • Stabilize processes and implement statistical process controls (SPC) to establish and maintain process capability using statistical methods
  • Apply inspection, measurement and sampling methods and participates in method improvements
  • Participates as an active team member in developing robust processes as part of the New Product Introduction (NPI)
  • Maintain and audit the plants audit readiness
  • Lead and guide plants external audits
  • Analyze, interpret and act on data (HACCP, Net Weights, and EQA) recorded and/or entered into the computer
  • Audit all aspects of our business to ensure the processes our compliant to our Quality and Food Safety standards
  • Interact with all levels of management to ensure the quality systems implemented are effective in their respective shifts and departments
  • Train employees as needed on Quality and Food Safety
  • As new quality programs are implemented, train and audit becomes ingrained in the practices of the employees
Qualifications for quality specialist
  • Must be able to provide leadership and be accountable in achieving required Portfolio quality results
  • Auditing qualification
  • Master degree in Economics/Accountancy/Finance/Computer Sciences/International relations
  • Good knowledge in accountancy, FS processes
  • Bachelor’s Degree, a degree concentration in Engineering, Life Science, Physical Science or a related emphasis on statistics and trend analysis is preferred
  • 2-4+ years of Medical Device or Pharmaceutical industry experience required with complaint management, post market vigilance, risk management, or compliance

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