QA Engineering

Quality Assurance Specialist
In this role, you will promote and verify Q&R input and controls are applied to servicing activities including distribution and service activities and that all current and future processes, tools, software and systems are designed validated and released in compliance with applicable Regulations and Standards.
Responsible for:

Quality Assurance in the processes related to the storage and distribution of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses.
The job will include the trend analysis and monitoring of processes and their environment, the remediation of field actions, and the development and improvement of Quality systems.
Providing support for regulatory actions and product containment activities (e.g., DPIAs, product holds, recalls, etc.).
Providing support of business operations for NPI/Sustaining projects ensuring on time completion of project deliverables, correcting issues delaying completion and reporting on QMS status of projects.
Providing support of operations during internal and external audit/inspections.
Performing other duties as required.
To succeed in this role, you should have the following skills, experience and background:

• Bachelor's degree in a Technical, Science, or Engineering discipline.
• 1+ years' experience in quality assurance in medical device or other highly regulated industry.
• Familiarity with appropriate global medical device regulations, requirements, and standards, such as ISO 13485:2016, 21 CFR Parts 803, 806, and 820. Familiarity with ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169 desired but not required.
• Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates.