Position : QMS Specialist : Verification & Validation
Role : The QMS Specialist : Verification & Validation will conduct various duties to support the QA department.
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 companyâ€™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 :
Bachelorâ€™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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