As a Quality Manufacturing Specialist for Soundbite Medical, your primary responsibility will be to apply your expertise and knowledge to identify, plan and conduct activities to ensure the Quality of Manufacturing of medical devices and components.
Responsible to bridge the gap between product & system engineering, production, supply chain and quality with respect to quality: compliance, improvements, and cost management. Work closely with the Production Development Team.
Work closely with Design Team to proactively ensure all manufacturing challenges are considered at early stage of the Design phases.
Manufacturing / Quality Supply Chain Management
- 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)
- Support the establishment of inspection and test methods;
- Lead Product design transfers to contract-Manufacturers/Suppliers.
- Management of DMR & DHR
- Management of receiving, in-process, and final inspection (including but not limited to supplier’s certificates records, inspection process for device final release, quarantine, disposition)
- 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, NC system, CAPA system and any other QMS
- Participate in investigations of such systems as, but not limited to, Nonconformance, Complaints, CAPA
- Develop & Monitor KPI’s for area of responsibility under QMS
General Quality Activities
- Other project activities as assigned by Management.
Experience, Skills, Knowledge Requirements:
- Experience with ISO 13485 or Medical Device Design requirements is an asset;
- Experience in Quality or Testing for Medical Devices is an asset;
- 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 an Engineering or a Science discipline
- Formal training in Medical Device Design Control Requirement is considered an asset