Senior Design Assurance Engineer

Position:
Senior Design Assurance Engineer
The role of Senior Design Assurance Engineer is to be the QA technical and compliance expert as part of a cross functional team for the design and development of sterile and non sterile medical devices and /or subsequent modifications thereafter in compliance to current Regulatory requirements i.e. ISO 13485, CFR 820 (QMSR) and governing Regulatory Standards associated with the product classification.
Lead the following activities from a quality perspective:
• Risk Assessments
• Device testing and associated validations
• Audits (internal and external), Support as SME for design processes.
• Generation and /or approval of technical documents on behalf of the Quality Function.
• Manage DHF
• On-going continuous improvement of the QMS
Key Responsibilities
• Responsible for compliance of product development and risk management activities with Versono Medical Policies and Procedures and applicable Governing Regulatory Requirements.
• Work effectively as part of product development team in identifying and translating user requirements and inputs into design requirements, identifying critical design features and components, and contributing towards or leading the generation of risk management documents and associated quality documents, reports etc .
• Complete design verification, design validation and test method validation activities associated with product development activities.
• Works with R&D and Manufacturing Engineering in translating design requirements into manufacturing requirements, including the development of manufacturing test methods and implementation of appropriate production process monitoring activities.
• Leads the resolution of project issues by working with team members, suppliers, and others as appropriate.
Apply thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
• Monitors compliance with Versono Medical policies, procedures and applicable regulatory requirements, identifying, reporting and implementing process and system improvements.
• Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to product development, manufacture and subsequent commercialization.
Apply statistic Techniques and analysis.
• Represent Versono Medical professionally and positively to external agencies, vendors and regulators.
Other responsibilities will include (but are not limited to) the following:
• Leads and/or facilitates compliance and improvement activities associated with the Versono Medical quality system (e.g. CAPA, audit programs, personnel training).
• Actively participates in and supports departmental activities and responsibilities in accordance with existing procedures and external regulations.
• Plan, execute, report and follow-up on quality system audits.
Act as an audit escort and/or support in the coordination of backroom activity during inspections as required.
• Makes decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve quality objectives.
• Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.
Assists department and project leaders in developing and reporting appropriate performance and quality metrics where applicable.
• Generate and /or Review and approves all operational, test and validation data associated with equipment, materials, components, sub-assemblies and final product to establish conformance to their corresponding technical specifications and performance standards.
• Provides technical quality guidance to team members, technician and inspection staff, including mentoring of junior staff when needed.
• System Administrator for Minitab.
• Ensure compliance to the QMS per QM001 quality manual as applicable.
Essential Skills/Experience
• Minimum Bachelor's Degree in Engineering, Science or related technical field.
• 6 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite.
Ideally includes a minimum of 4 years in the QA activities associated with product design and development including project management skills and leadership ability.
• Knowledge of FDA's 21 CFR Part 820 (QMSR), ISO 13485:2016, the European Medical Device Regulations, the Canadian Medical Device Regulations and other international standards and regulations.
• Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
• Excellent interpersonal skills and ability to work with people to achieve results.
• Excellent written and communication skills, fluency in English.
Proficiency in MS office products.
• Experience in the preparation for notified body and FDA inspections, and active participation in discussions with auditors.
• Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both Versono Medical and their customers.
• Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
• Good business acumen.
Note: As wit h all positions, due to the dynamic nature of business, key responsibilities will evolve and change over time.
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