Job Description:
We are seeking a Sr Software Quality Engineer for a very important client
Responsibilities may include the following and other duties may be assigned:
Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures
Define appropriate measures to ensure software quality
Actively participate in new product development lifecycle by engaging with cross-functional partners in early development phases on design concepts, development strategies, risk management, and verification and validation test approaches
Support Software New Product Development, Design Control, and Design Transfer processes, as well as responsibility for Quality deliverables during product development
Lead risk management activities and participate on cross-functional teams to develop and maintain Product Risk Management Files
Identify and implement software process metrics for the software product development lifecycle
Provide solutions to a wide range of difficult challenges Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives
Follow all Quality System Practices as defined by Client Navigation's practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable
Requirement:
Must Have
Agile Software Development practices
Bachelor's Degree in Engineering, Science or technical field with 5 years of work experience in Engineering and/or Quality OR Master's Degree Engineering, Science or technical field with 3 years of work experience in Engineering and/or Quality Expertise in CAPA compliance & investigation techniques Auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR, the Medical Device Directive and MDSAP Training in Risk Management, ISO 14971:2012, hazard analysis, and Design FMEA Must work well in cross-functional teams and be a self-starter Excellent written and verbal communication skills Excellent organizational skills Computer literacy must include proficiency with MS Office and experience with networks and applications.
Nice To Have
5 years of experience supporting new product development activities in medical device
Top 3 technical skills that are required for the role:
1. Risk management: experience in assessing and mitigating risks associated with SW development in medical devices following ISO 14971.
2.Software development life cycle (SDLC): experience in SDLC for medical device, or highly regulated industry.
3.SW verification and validation: experience in testing methodologies.

Education Required: Minimum: BS in technical areas.

Years' Experience Required: minimum: 7 years.
Requires a University Degree and minimum of 6 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience.