SoundBite Medical Solutions Inc. is developing proprietary shockwave technology to address significant unmet clinical needs in interventional vascular treatment. Through an elegant combination of hardware and software, it can, in a very controllable manner, deliver high amplitude shock wave pulses through guidewires and other interventional tools, to specifically attack highly calcified and fibrotic tissue in the vascular system, while leaving healthy, elastic arterial walls unharmed
SoundBite is currently seeking a Quality Specialist, Disposables & Systems to join the Quality Engineering and Assurance team in Montreal.
Your primary responsibility in this position will be to apply your expertise and knowledge to identify, plan and conduct activities to ensure the quality of manufacturing and design of disposables & related systems. In this position, you will be responsible to bridge the gap between product & system engineering, production, supply chain and quality with respect to quality, compliance, improvements, and cost management while working closely with the Quality Specialist, Console Systems and leading Risk Management for the Disposables & System department
Role and Responsibilities:
- Proactively ensure all manufacturing and design challenges are considered at early stage of the design phases.
- Lead product risk management according to regulatory requirements and ensure Gate Reviews are conducted and DHF is well maintained as per SoundBite relevant procedures.
- Run Design FMEA’s and identify testing & inspection for Design Verification & Validation plan.
- Review Develop and Implement Inspection requirements and Inspection plans.
- Develop, qualify, and validate methods for testing, inspection and evaluation of all finished devices.
- Assess and approve related Engineering Change Orders (ECR)
- Run Process FMEA’s and identify Critical controls (Validation vs Inspection);
- Establish Quality Plan: Inspection Plan & validation Master Plan;
- Design & execute test protocols & write test reports (process validation);
- Lead product design transfers to contract-manufacturers/suppliers;Ensure DMR & DHR are properly maintained;
- Proactively develop supplier’s qualification relationship by supporting SoundBite processes;
- Support all relevant investigation through structured approach (RCA);
- Assess and approve related Engineering Change Orders (ECR).
- Quality Management System
- Develop internal training sessions on quality and compliance;
- Ensure all relevant procedures are well understood (training), implemented & followed: Design & Process Control, NCM system, deviation system, CAPA system, etc.;
- Develop & monitor KPI’s for area of responsibility under QMS.
Experience, Skills, Knowledge Requirements:
- Experienced with ISO 13485 or Medical Device Design requirements;
- Background in interventional radiology or cardiovascular devices, an asset;
- Detail and team oriented;
- Strong technical writing skills;
- Excellent communication and organizational skills;
- Strong project management skills;
- Ability to work independently on several projects;
- Strong interpersonal skills (ability to foster teamwork that ensures compliance).
- Bachelor’s degree in engineering or a science discipline or equivalent experience with a minimum of two years in Quality or medical device testing;
- A formal training in Medical Device Design Control Requirement an asset.