Quality Management Systems Job Description
Quality management systems
provides rigorous assessment of quality system activities and documentation to assure compliance with policies and procedures, FDA regulations, ISO 13485, and other Medical Device requirements.
Quality Management Systems Duties & Responsibilities
To write an effective quality management systems job description, begin by listing detailed duties, responsibilities and expectations. We have included quality management systems job description templates that you can modify and use.
Sample responsibilities for this position include:
Serve as the central point of linkage across the BioResearch Quality & Compliance (BRQC) Janssen organization to oversee monitoring of quality issues identified across segments of the organization and lead the development and execution of strategies for providing QMS (Quality Management Systems ) monitoring
Facilitate and coordinate all aspects of performing international recall activities in a timely manner
Create regulatory recall reports, write and/or review field advisory notifications
Follow up on all aspects of recalls on a regular basis and report on status and trends
Prepare and deliver training material and seminars for recalls and other QMS topics
Utilizes excellent communication skills to prepare technical written and verbal communications to stakeholders, regulatory affairs, and customers
Be a certified ISO9001 Lead Auditor with IRCA or equivalent for third party assessments
Have substantial experience in third party auditing/assessment in a wide range of industry sectors including system level auditing and process level auditing
Possess a high standard of personal presentation, excellent communication skills, both written and verbal in Spanish and English, and a flexible attitude
Have the ability to travel extensively throughout Panama, and Central America / Mexico if needed
Quality Management Systems Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality Management Systems
List any licenses or certifications required by the position: ISO, ASQ, 9001, QMS, IATF, MDSAP, US, FDA, CQE, AS9100
Education for Quality Management Systems
Typically a job would require a certain level of education.
Employers hiring for the quality management systems 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, Business, Computer Science, Education, Life Sciences, Management, Manufacturing, Information Technology
Skills for Quality Management Systems
Desired skills for quality management systems include:
Quality Management Systems
ISO 13485
Global health authority regulations and requirements
Regulations
Similar quality system
With the ability to effectively translate and communicate these requirements
Audit Management
Audits
Desired experience for quality management systems includes:
Hold a degree (or equivalent qualification) in a relevant subject
Provides guidance to IT department on interpretation and application of procedures applicable to the implementation and operation of IT systems
Works with project managers to establish work scheduling plans in support of project schedules
Serve as a critical driver in the BioResearch Quality & Compliance (BRQC) Janssen organization to ensure the efficiency and effectiveness of the corrective and preventative action (CAPA) process
Lead a team and contribute to the effective and accurate implementation and delivery of global GxP CAPA management in Janssen R&D
Ensure continuous improvement of the Janssen R&D CAPA process to align with enterprise and global processes
Quality Management Systems Examples
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Quality Management Systems Job Description
Job Description Example
Our company is looking for a quality management systems. 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 systems
- Coordinate and conduct internal ISO and RCMS audits
- Support the business segments to plan and perform internal Quality Management System (QMS) audits to ensure work practices meet or exceed the standard
- Internal audits development and audit process ownership
- Liaise with key business partners to drive alignment and collaboration in GCP CAPA process oversight
- Establish and oversee an independent escalation method to support global GCP CAPA governance
- Interact with key senior leaders to maintain executive awareness of GCP CAPA performance
- Establish and drive the use of accurate and actionable metrics for clearly identifying areas of risk, performance to commitments, effectiveness and timeliness of GCO CAPAs
- Support Regulatory Inspection readiness initiatives and activities across GCP disciplines/segments, as appropriate
- Maintain appropriate level of expertise in US and international GCP regulatory requirements, policies, SOPs and unit/project-specific procedures within Janssen applicable to the processes and systems within the scope of the R&D QMS
- Develop and implement a strategy to examine the business for compliance intelligence with visibility to review and assess the overall control state of the QMS cross BRQC Janssen/GxP to sustain effectiveness and continuous improvement in the QMS
Qualifications for quality management systems
- This position will be based at any Janssen facility worldwide and may require up to 25% domestic and international travelR&D
- A Bachelor of Science (BSc) or equivalent degree is required
- Drive projects to design processes for knowledge share across GxP disciplines within BRQC, Janssen R&D to eliminate causes of detected quality risks, and ensure preventive actions are in place to eliminate causes of potential discrepancies or other undesirable situations
- Lead independent monitoring across QMS process (includes monitoring CAPAs, quality events, systems and data) to ensure attainment of short-term goals
- Establish and lead an efficient and effective governance program to accurately track and proactively manage the CAPA process, deliverables, status and metrics globally across disciplines (GLP, GCP, PV)
- Ensure the effective functioning of CAPA system/process to eliminate the causes of detected discrepancies (reactive), preventive actions are in place to eliminate the causes of potential discrepancies of other undesirable situations (proactive)
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Quality Management Systems Job Description
Job Description Example
Our growing company is hiring for a quality management systems. 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 systems
- Remain abreast of changes in relevant regulations including product testing, clinical trial, product registration and post-marketing action both proposed and implemented
- Track quality system records
- Trend quality system records
- Provide support during regulatory and other inspections
- Supervise the quality team to effectively manage customer complaints, specification reviews, and associated quality activities
- Lead the efforts to maintain and enhance the RCMS certification by working with global quality, EHS, registrars, and the sites
- Maintain the Care Chemicals Group level quality documents
- Serve as a critical driver role in the BioResearch Quality & Compliance (BRQC) Janssen organization to ensure the efficiency and effectiveness of the corrective and preventative action (CAPA) process
- Support and contribute to the effective and accurate implementation and delivery of global GxP CAPA management in Janssen R&D
- Manage continuous improvement of the Janssen R&D CAPA process to align with enterprise and global processes
Qualifications for quality management systems
- Six Sigma belt certification, ASQ CQE and/or formal training in CMMI V
- Typically requires a Bachelors, Masters or PhD in engineering or a related technical field thirteen or more years of progressively complex QA experience with at least seven of those years having management responsibilities
- Product knowledge – must have working knowledge of product usage and failure modes
- High level of problem identification, analysis, and formulation of conceptual / technical and business solutions
- Strong product knowledge of clinical application usage and/or manufacturing process
- Must be able to provide support to Customer Facing Teams
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Quality Management Systems Job Description
Job Description Example
Our growing company is hiring for a quality management systems. 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 management systems
- Coordination, organizing and managing L3 & L4 Audits coordinating, managing /reporting /follow-up of Regulatory /Corporate (level 4 & Level 3) audits
- Support and contribute to the effective and accurate implementation and delivery of global GCP CAPA management in Janssen R&D
- Liaise with key business partners to develop alignment and collaboration in GCP CAPA process oversight
- Manage an independent escalation method to support global GCP CAPA governance, and support the escalation of individual CAPAs at risk and/or negative trends in Key Performance Indicators
- Utilize accurate and actionable metrics to identify areas of risk, performance to commitments, effectiveness and timeliness of GCP CAPAs
- Subject matter expert providing/assisting support of quality system tools (eg
- Of procedures and practices by converting process inefficiencies into improved business practice
- Establish departmental policies, procedures, goals, and objectives and drive achievement of objectives
- Ensure the corrections of findings, risks and recommendations are promptly and thoroughly incorporated into the quality systems
- Identify, monitor and report on success metrics for quality initiatives
Qualifications for quality management systems
- Knowledge of health care operations, with a focus on quality management, patient relations and risk management services in acute and non-acute outpatient settings is strongly preferred
- Strong evidence of critical thinking skills
- Must be motivated, self-directed, and able to work with minimal supervision
- Ability and skill to lead or manage the Quality System function for complex systems, continuous improvement projects and project management techniques
- Communicate precisely and accurately to all levels of the organization
- Computer-based analytical, statistical and modeling tools are used to identify and improve processes
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Quality Management Systems Job Description
Job Description Example
Our company is looking to fill the role of quality management systems. 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 management systems
- Because we contract with the US Department of Defense we are bound by International Traffic in Arms Regulations (ITAR)
- Identify, plan, lead or/and particiapte in producy/process/systems audits - IATF-16949, VDA, BIQS
- Executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations
- Gather and formalize business requirements
- Configure applicable system changes
- Champion system testing
- Provide training and mentoring
- Support operations management
- Collaborate with project managers, scrum masters, and architects
- Provide strategic direction and leadership to identify and eliminate the causes of systemic issues
Qualifications for quality management systems
- Temperaments/Mental Requirements
- The position requires concentration as errors might cause moderate to serious delays, confusion, or expense to correct
- The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper
- Must be able to communicate clearly and professionally both in writing and verbally
- Bachelor’s degree with eight (8) or more years of experience in Quality, Engineering or in a related area
- Experience implementing and maintaining quality systems (ISO 9001/TS16949)
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Quality Management Systems Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of quality management systems. 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 systems
- Oversee the quality management system internal audit program external audits
- Act as stakeholder representing the customer perspective
- Interface with functional managers and designees to review and update training needs relative to quality system documents
- Work with subject-matter experts (SMEs), trainers, and other key stakeholders in developing new or revising existing training matrices/training groups
- Work with the LMS Administrator to learn the requirements for loading new content/knowledge assessments
- Create a Work Instruction to support the maintenance of Training Matrices and interactions with the LMS system
- Able to effectively schedule meetings with functional managers and others to accomplish completion of project
- Will report progress to supervisor weekly
- Processing of receipt inspections under the direction of a receipt inspector
- Scanning, filing, and other administrative duties
Qualifications for quality management systems
- Certified Lead Auditor to ISO 9001 standards by acknowledged accreditation body (e.g., Exemplar Global, Probitas Authentication, AMP Group)
- ASQ Certification, Certified Quality Engineer, Certified Auditor, Certified Quality Manager or equivalent industry certifications
- Experience as a registrar auditor
- A minimum of 3 years of QMS experience
- Practical operational experience of working across disciplines and across multiple regions
- Knowledge Sharing – ability to capture knowledge within (and from outside) the organization