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Qms Coordinator Jobs

Remote: Qms Sme (233782) Jobs
By Black Diamond Networks At United States

Job Description Our client is looking for a QMS SME with a background in pharmaceutical distribution for a 3 month assignment. This person will help to assess and approve SOPs, policies, and ...

Qms/ Qa Specialist Jobs
By Steri-Tek At Lewisville, TX, United States
Complete continuing education requirements described during performance review
Complete any task assigned by the Quality Manager
Ensure that Steri-Tek follows ISO requirements and other regulatory standards including ISO 11137:2006 and AAMI TIR 29:2002
Assist the Quality Manager in Training, CAPA, Non-Conformance, Complaint, Calibration, Preventive Maintenance and Audit programs
Manage due dates and implementation dates for QMS programs
High School Diploma or equivalent experience
Project Manager/Qms Jobs
By EG Life Sciences At United States
*Project management experience – PMP is a plus.
This is a 6+ month remote based project.
*Strong background in QMS based project for Medical device.
*Must be able to work West Coast hours
Quality Engineer (Qms) Jobs
By Cannon Quality Group, LLC At United States
Manage the supplier/vendor qualification program and Approved Supplier/Vendor List, including Quality Agreements with contractors, suppliers and vendors
Ability to prioritize and manage to critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently
Partner with R&D on EMC and safety (UL/CSA) certification
Lead and Manage activities for receiving inspection, device history records, component release and process validation
Lead, manage, and approve DMR, DHR, and Validation Protocols and Reports related to processes, equipment, facility and computer systems
Manage the equipment calibration program
Senior Quality Management System (Qms) Associate
By Amicus Therapeutics At , Princeton, Nj
• • Experience in database management, reporting and trending systems.
• • Previous Master Control, TrackWise, Documentum, Compliance Wire or Learning Management experience required
Senior Quality Management System (QMS) Associate
10. Support Quality Management System as needed or project activities.
5 to 10 years’ experience working in a regulated industry (Pharmaceutical, Biotechnology or Devices).
BA or BS in related technical field is required
Qms Administrative Assistant Jobs
By Gaming Laboratories International, LLC At Colorado, United States
We Offer Excellent Paid Benefits That Include
Strong multi-tasking, verbal and written communication skills are required.
Provide support for the Gaming Labs Certified mark program
Provide administrative support for GLI’s global QMS programs for gaming, voting and health IT
Provide administrative support for the GLI University program
Answers telephone, mail, and e-mail correspondence, providing general information and taking messages, as needed
Quality Management System (Qms)/Qualio Lead
By Ginkgo Bioworks At , Boston, 02210, Ma
Experience with Quality Management Systems and/or Document Management Systems
SME (subject matter expert) and system owner for Quality Management System Implementation and Oversight
Support Quality System stakeholders with workflow management and electronic system usage
Experience managing teams, programs, or directing allocation of resources
Interpersonal skills, written and verbal communication
Collaborate with external stakeholders to identify gaps and resolve QMS related issues
Quality Management System (Qms) Specialist
By SHL Medical At Charleston, South Carolina Metropolitan Area, United States
Knowledge of and ability to use process management tools
Support compilation and presentation of Management Review meeting documentation package
Assist with the implementation of QMS to obtaining ISO 13485 site certification for SHL in Charleston, SC
Conducts internal and supports external audits as assigned to ensure compliance to company quality systems requirements
Expert knowledge of ISO 13485
Customer orientation and the ability to identify and effectively manage stakeholder expectations
Qms Manager Jobs
By Agilent Technologies At Atlanta, GA, United States
Minimum of 7 years supervisory experience (managing direct reports), including hiring, training, coaching and performance management activities
Act as the Training process owner and support implementation of a global Learning Management System (LMS).
Oversee preparation and provide direction on the content of Quality Management Review (QMR) in alignment with global standards and initiatives.
Minimum of 7 years professional experience in Quality in the medical device industry
Strong knowledge and understanding of standards and regulations: ISO 14971:2019, Regulation (EU) 2017/746, FDA CFR 21 Part 820, ISO 13485
Direct experience in managing QMS processes under above regulations
Medical Device Qms Consultant
By Isometric Consulting Group, LLC At Michigan, United States
5–10 years of experience implementing and auditing medical device management systems
Coach the client on general quality management principles.
ISO 13485:2016 certifications are required.
Prepare DHf and biocompatibility studies.
Create the SOPs to support the activities for sales, import, distribution, etc. of the device.
Support the closure of internal and registrar audit findings.
Ems, Ohs, Qms Auditor - Part-Time
By Intertek At ,
Education and Advanced coursework, training or experience in environmental, safety and quality management required.
Experience in implementation of and/or auditing ISO management systems
Evaluate clients’ management systems through documentation review, onsite observation, and interviews.
Train, mentor, witness (as part of the auditor qualification process) audit team-mates if requested.
5+ years of professional experience in industry.
Knowledge of the principles and practices of manufacturing systems.
Qms Manager - Actalent
By Actalent At Edgewood, NY, United States
Act as management representative per FDA and ISO requirements
Conduct: internal audits, management reviews, retain sample reviews, supplier reviews, repair trend analysis
Creation and revision of EU Tech Files: CER’s, Risk Management, ER Checklists, etc.
Manage entire QMS, except Product Design Control
Manage systems: Product Non-conformance, Complaints, CAPA, Document Control, Calibration
Manage and approve drawing/procedure releases

Are you looking for an exciting opportunity to join a dynamic team as a QMS Coordinator? We are looking for a highly motivated individual to join our team and help us maintain our Quality Management System. You will be responsible for ensuring compliance with applicable regulations and standards, as well as developing and implementing quality assurance processes. If you have a passion for quality and a drive to succeed, this could be the perfect job for you!

Overview:

QMS Coordinators are responsible for ensuring that an organization’s quality management system (QMS) is properly implemented and maintained. They are responsible for developing and maintaining quality standards, procedures, and processes, as well as ensuring that the organization meets all applicable regulatory requirements.

Detailed Job Description:

QMS Coordinators are responsible for developing, implementing, and maintaining quality management systems and processes. They must ensure that the organization meets all applicable regulatory requirements and that the QMS is properly implemented and maintained. This includes developing and maintaining quality standards, procedures, and processes, as well as conducting audits and reviews to ensure compliance. They must also ensure that the organization’s quality objectives are met and that any non-conformances are addressed in a timely manner.

What is Qms Coordinator Job Skills Required?

• Knowledge of quality management systems and processes
• Knowledge of applicable regulatory requirements
• Ability to develop and maintain quality standards, procedures, and processes
• Ability to conduct audits and reviews
• Ability to identify and address non-conformances
• Strong organizational and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

What is Qms Coordinator Job Qualifications?

• Bachelor’s degree in Quality Management, Engineering, or a related field
• Certification in Quality Management (e.g. ISO 9001, ASQ CQE, etc.)
• 5+ years of experience in quality management

What is Qms Coordinator Job Knowledge?

• Knowledge of quality management systems and processes
• Knowledge of applicable regulatory requirements
• Knowledge of quality assurance tools and techniques
• Knowledge of statistical process control

What is Qms Coordinator Job Experience?

• 5+ years of experience in quality management
• Experience in developing and maintaining quality standards, procedures, and processes
• Experience in conducting audits and reviews
• Experience in identifying and addressing non-conformances

What is Qms Coordinator Job Responsibilities?

• Develop and maintain quality management systems and processes
• Ensure that the organization meets all applicable regulatory requirements
• Develop and maintain quality standards, procedures, and processes
• Conduct audits and reviews to ensure compliance
• Identify and address non-conformances
• Ensure that the organization’s quality objectives are met
• Monitor and report on quality performance