QMS Specialist: Verification & Validation
Toronto, Ontario, CA
6d ago

Position : QMS Specialist : Verification & Validation

Role : The QMS Specialist : Verification & Validation will conduct various duties to support the QA department.

Responsibilities :

  • Maintain the Myant Quality Manual through the authoring of new content and updating existing content as well as ensuring the format and records associated with the Manual are current and in compliance
  • Create or support company functions in developing Quality Management System controlled documentation such as Standard Operating Procedures (SOP) and company policies
  • Facilitate the Corrective Action and Preventative Action (CAPA) process by tracking, monitoring and reporting on CAPA status and actions plans through to CAPA closure
  • Develop and revise quality system procedures (SOPs, WIs, etc.)
  • Develop and maintain risk management files and quality control plans for components, devices and processes.
  • Prepare and support internal / external audits and inspections.
  • Administer the company’s complaint handling process by monitoring complaints, proposing changes or customer feedback progress appropriately and are adequately addressed
  • Contribute to the development and delivery of quality training for staff across the organization
  • Identify and introduce improvements in quality and business processes
  • Promote and instill the principles of quality in collaborations with colleagues across the organization
  • Participate in opportunities to develop quality and medical device business knowledge
  • Participate, and adhere to, health and safety initiatives and requirements
  • Manage the document control and update the master document control and BOM
  • Develop / write protocols and coordinate the testing for verification / validation activities, component qualification activities, IQ / OQs, and test method validations.
  • Provide training and / or technical guidance to production staff as required.
  • Support supplier and / or material qualification activities for all new / modified articles.
  • Support the review and timely completion of Nonconformance, Deviation and CAPA reports.
  • Support to manage ECR, and ECN
  • Verification and Validation

  • Understanding of software development process for medical devices
  • Familiarity with hardware, firmware and software design and documents
  • Understanding of the relation between software requirements, unit tests, integration tests and system tests
  • Ability to understand circuit schematic and software documents such as class, objects, and sequence diagrams
  • Proficiency using test jigs to execute tests plans and verify hardware and firmware functionalities of a medical devices
  • Proficiency using oscilloscopes, multimeters, and function generators to verify PCBs and jigs
  • Constantly review the project documentation to assure traceability between requirements and tests
  • Understand the interaction between hardware, firmware and software and be able to isolate issues between them
  • Writing test plans, test procedures and other activities involving performance, durability, and reliability assessments
  • Understand device design and core technologies in order to inform test method development
  • Determining test coverage for revisions to design
  • Creating and evaluating test fixtures needed for product design verification
  • Contributing to design failure investigations that may impact Risk Assessment, Hazard Analysis, and FTA's
  • Participating and contributing towards Regulatory and Agency submissions
  • Authoring Quality Plans, Test Summaries, and other documents
  • Work with engineering and manufacturing teams to create test plans
  • Capable of analysing change requests and define and execute regression tests
  • Qualifications Required :

  • Bachelor’s degree in Biomedical or Electrrical engineering or computer science
  • Post-graduate diploma or certification in Quality and Regulatory is an asset
  • Over 5 years of experience as a V&V engineer with expertise in validation methodologies, technical writing and quality assurance in the medical device software arena.
  • Previous experience working in Quality Assurance positions operating under Quality Management Systems in the medical device or pharmaceutical manufacturing companies (approx. 3+ years)
  • Firsthand experience with validating web applications for FDA Quality Systems Regulations would be very desirable
  • Must have strong background using Linux machines, command line , Python, and bash script
  • Expertise in the knowledge and use of various regulations and standards such as, IEC-62304 / 60601
  • Expertise in using test and defect management tools such as TestRail, DevOps, HP Quality Center, TFS, ASANA and notion
  • Expert in producing high quality documentation with a strong attention to detail.
  • Proficient in creating V&V team plans that span contributors across multiple organizations that are globally distributed.
  • Proficient with Rapid Applications Development principles and modern and traditional software development methodologies
  • Understanding and working knowledge of ISO Quality Standards (13485), FDA Quality System Regulation and / or Good Manufacturing Practices
  • Teamwork-oriented approach to achieving goals
  • Strong verbal and written communication skills
  • Excellent organizational ability and attention to detail
  • Ability to multi-task, prioritize duties and execute tasks in a timely manner
  • Strong self-initiative and work ethic
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