Quality Systems Specialist Job Description

Quality Systems Specialist Job Description

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Quality systems specialist provides quality System expertise to the organization and ensure compliance to ISO 13485, QSR and other applicable Quality System Regulations by supporting interpretation of regulations, lead gap analysis and activities to implement improvements.

Quality Systems Specialist Duties & Responsibilities

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

Sample responsibilities for this position include:

Providing on site QA and QC, GMP compliance support
Maintaining GMP compliance of the company's products
Assessment of the company's operational and quality compliance gaps from GMP and best operational practices
Provide on site QA and QC, GMP compliance support
Maintain GMP compliance of the company's products
Compiles contextualizes, evaluates and presents Quality Systems data and metrics for all metric review meetings
Actively participate in determining the goals and plans for PAS Quality Systems management and improvement
Collaborating with the company's QA colleagues as appropriate ensuring all appropriate batch related documents and processes for finished product packs are available from the operations to enable the release of products
Participating in the investigation of quality related deviations and support execution and monitoring of corrective and preventative actions (CAPA) which ensure compliance is achieved and maintained
Identification and recommendations of improvement of the company's functions interactions which impact and support product quality and availability

Quality Systems Specialist Qualifications

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

Licensing or Certifications for Quality Systems Specialist

List any licenses or certifications required by the position: ASQ, TSE/BSE, SSBB, ISO, FAA, USDA, CQE, CQA, AS9100, SAE

Education for Quality Systems Specialist

Typically a job would require a certain level of education.

Employers hiring for the quality systems specialist 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, Education, Technical, Chemistry, Manufacturing, Business, Biology, Medical, Microbiology

Skills for Quality Systems Specialist

Desired skills for quality systems specialist include:

ISO 13485
MDD
GMP
Excel
Quality Systems
Regulations
CMDCAS
ISO 14971 and other applicable standards and regulations
JPAL

Desired experience for quality systems specialist includes:

Recommending remediation plans required to secure continued on time, in full compliant product
Following up the company's quality investigation queries by onsite review with facility, procedures, practices and records
Facilitating and coordinating change control processing which impact routine batch release
Providing regulatory inspection support for inspections which impact the company's products and follow up any resulting quality improvement or remediation action plans
Collaborate with the company's QA colleagues as appropriate ensuring all appropriate batch related documents and processes for finished product packs are available from the operations to enable the release of products
Participate in the investigation of quality related deviations and support execution and monitoring of corrective and preventative actions (CAPA) which ensure compliance is achieved and maintained

Quality Systems Specialist Examples

1

Quality Systems Specialist Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality systems specialist. 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 systems specialist
  • Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance efficiency throughout our quality system
  • Interact with internal and external partners for development of best practices in our quality systems and procedures
  • Ensure Customer complaint investigations, procedures and other activities comply with FDA Quality System Regulations, ISO and Medical Device Directives for Vigilance
  • Experience of Compliance, Quality Systems or Quality Assurance within a Medical Devices and Diagnostics and other regulated, healthcare industries is required
  • Experience with multiple, global quality systems such as Audits, CAPA, Non-Conformance, Change Control, Design Controls and Document and Data Control, Training and Records Management to include the use of process excellent methodologies for new initiatives and process/system improvements
  • Developing professional expertise, applies company policies and procedures to resolve a variety of quality systems issues
  • May provide assistance to lower level staff with general tasks that require a better understanding of quality systems functions, as directed by immediate supervisor
  • Prepares audit and product evaluation schedules
  • Installs and calibrates new equipment
  • Performs investigations of media type or equipment issues, documents findings, and makes recommendation for improvement activities
Qualifications for quality systems specialist
  • Orders and replaces consumable items needed for testing
  • Participates with stakeholders to develop potential preventive or corrective actions and implementation
  • 5 years relevent experience preferred
  • Ability to work in teams, including large multifunctional teams, and independently obtain results as required with minimal supervision
  • Ability to identify, analyze, develop and present solutions for problems of moderate scope and complexity
  • Ability to collect, analyze data and present results to others orally or in writing
2

Quality Systems Specialist Job Description

Job Description Example
Our growing company is looking for a quality systems specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality systems specialist
  • Solid understanding of the efficiencies and criticalities of all of the quality systems elements at BBMI
  • Executes the strategic direction for Quality Systems Excellence Programs & Deployment Management
  • Creates standard informatics methods for introducing, updating, tracking and trending Quality Systems Metric
  • Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, quality records, ) as needed
  • Review of batch record to support release of raw materials, work in progress and final products
  • Review batch record to support release of raw materials, work in progress and final products
  • Maintenance of all documentation regarding Quality System implementing Policies, SOP's, Work instructions, Job Aids, Validation documents, checklists, forms, including distribution of controlled hard copies, posting of controlled electronic copies and
  • Execution of purchase requisitions in CostPoint
  • Monitor Funds Release Memorandums (FRMs) as they are provided by Contracts and work with manager and Quality Engineers for assignment
  • Generate metrics for Management, Quality Engineers, and CABs to review, monitor trends, and take action
Qualifications for quality systems specialist
  • Self-motivated, organized, detail oriented, and able to multi-task
  • Ability to develop work plans and manage them to meet agreed upon goals
  • Skilled in Microsoft software
  • Working knowledge of risk analysis tools
  • Experience in a regulated environment (ie FDA, USDA) - preferred
  • Working knowledge of quality auditing - preferred
3

Quality Systems Specialist Job Description

Job Description Example
Our company is looking to fill the role of quality systems specialist. 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 systems specialist
  • Update and maintain myLearning curricula for Global Quality Systems team and Global Quality, Strategy & Compliance teams
  • Support Quality Systems initiatives, including implementation of myLearning for LOCs
  • Contribute to overall Quality Systems training strategy
  • Partners with Quality Operations at all BBMI sites on quality objectives related to quality systems and processes
  • Schedule meetings and track action items
  • Periodically check or audit the completion process of factory check sheets
  • Drive the closure of all factory quality NCRs
  • Generate status and trend reports to management, including preparation of information for Management Review meeting
  • Assist in drafting responses to external assessments/audits/inspections
  • May actively participate as the PAS representative of the Supplier Management Action Team (SMAT)
Qualifications for quality systems specialist
  • Experience with root cause analysis tools preferred
  • Proficient working with electronic records databases Microsoft Office and Minitab
  • Demonstrated ability to learn new software systems to perform basic functions
  • Bachelor’s degree in Science course or Engineering/ Quality Management or related discipline
  • Ability to work in a team environment independently and with minimal supervision
  • Experience in management of exception systems
4

Quality Systems Specialist Job Description

Job Description Example
Our innovative and growing company is hiring for a quality systems 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 systems specialist
  • May serve as CAPA Site Leader for PAS, Franklin Lakes, NJ
  • Communicate risks and compliance/regulatory issues to management
  • Support and develop systems for the identification, analysis, correction, and prevention of quality issues
  • Administers assigned Quality Process
  • Help establish systems for tracking progress and providing updates for key processes and projects (Supplier Scorecards, supplier performance, material change activities)
  • You will perform and/or supervise the conduct of internal audits and assessments
  • Manage the process of the complaint handling system including routing the complaint and any returned samples to the appropriate persons, functions and or manufacturing site for further evaluation and investigation
  • Demonstrate technical competencies in clinical (medical), mechanical and functional disciplines in relation to all Diabetes Care products
  • Provide internal awareness of noted trends, escalated customer concerns and or quality issues which can significantly impact the health of the user of any Diabetes Care device
  • Follow all applicable Company / Unit policies and procedures and make updates to Unit procedures
Qualifications for quality systems specialist
  • Experience with GxP Electronic Systems
  • Bachelor’s Degree in Quality, Quality Management, Logistics, Business, or Business Management AND 2-5 years of applicable experience
  • Working knowledge and understanding of basic quality management principles
  • Ensure appropriate quality system performance particularly CAPA, Change Control, and Deviation performance by being the business process owner and directly working with cross functional teams and projects
  • Evaluate trending results, determine root causes and advise in solving and preventing the cause
  • Support the Quality Management Review
5

Quality Systems Specialist Job Description

Job Description Example
Our company is hiring for a quality systems specialist. 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 systems specialist
  • Responsible for the design, development, delivery, and evaluation of both traditional classroom and e-learning instruction
  • Conducts ongoing and comprehensive Learning Management System (LMS) training needs assessments
  • Designs learning activities and materials
  • Develops and implements elements of a competency-based training program (competency mapping, job task analyses)
  • Identifies measurable objectives/outcomes and develops instructional materials (presentations, in-class activities, assessments, e-learning modules, documentation, work instructions, OJTs)
  • Designs and delivers highly engaging, creative, and effective classroom/online instruction
  • Provides support during FDA and other regulatory body inspections
  • Normally receives general work instructions on routine work and detailed instructions on new projects or assignments
  • At a minimum a degree in a Quality, Science or Engineering discipline and 3 or more years of related experience
  • Accurately and effectively execute standard system administration activities
Qualifications for quality systems specialist
  • Oversight of multiple (global) Quality Systems and their interaction within Janssen Vaccines Leiden and J&J
  • Keep procedures related to activities for QA up-to-date, identify and implement improvements
  • At least 5 years working experience in a GMP regulated environment with relevant knowledge in QA
  • Degree in Life Sciences, Engineering or related experience (sterile manufacturing)
  • Computer skills, , word, excel, access, Microsoft project, electronic documentation systems, ERP systems
  • Must show innovative development techniques and strategic thinking abilities

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