What are the responsibilities and job description for the Quality Systems Engineer - software compliance, medical device position at InnoTech Staffing?
Job Description
Job Description
InnoTECH Staffing is looking to hire a Quality Systems Engineer / Software Compliance for a product development company in Southern New Hampshire. This is onsite 5 days a week. No sponsorship at this time.
Join our client's dynamic team and be at the forefront of driving quality excellence! As their Quality Systems Engineer, you'll be a key player in their collaborative environment, working hand-in-hand with cross-functional teams to ensure the highest standards of quality and compliance.
As a Quality Systems Engineer, you will contribute in the following areas :
- Attain a comprehensive understanding of FDAs medical device software development requirements, leveraging this knowledge to champion improvement initiatives within the Quality Management System (QMS) and actively seeking opportunities to enhance company’s software development procedures.
- Develop and revise Standard Operating Procedures (SOPs) and associated change controls, ensuring alignment with regulatory requirements to support company’s software development processes.
- Lead collaborative efforts to drive internal investigations and improvements by ensuring comprehensive analysis and appropriate solutions are implemented by cross-functional teams.
- Ensure compliance with FDA Part 820 and ISO 13485 regulatory standards, maintaining the integrity and effectiveness of the QMS.
- Review and approve quality records to ensure accuracy, completeness, and compliance with regulatory requirements.
As a key contributor to our team, you will demonstrate the following skills :
Required Training / Knowledge :
Knowledge of FDA’s Quality System Regulation
