Job Description
Job Description
Title Engineer, Software Quality
Duration: - 12+ Month
This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering and Risk assessment support for software utilized throughout the division.
Duties:
- Work with Design and Test Engineering in the completion of system/software requirements and other verification and validation processes.
- Review software validation protocols traceable to system/software requirements.
- Participate in meetings and provide guidance on Software Event/Defect or anomalies.
- responsible for driving the completion and maintenance of risk analysis, focused on software related risks.
- Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing).
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
- Software scoping and Part 11 audits.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
-Performs other related duties and responsibilities, on occasion, as assigned.
Qualifications:
- BS degree in Engineering or Technical Field or equivalent experience.
- At least 5 years Quality Engineering experience.
- Detailed knowledge of FDA QSR, IEC 62304, and ISO 13485.
- Advanced computer skills, including data analysis and report writing skills.
- Prior medical device or IVD experience preferred.
- ASQ CSQE certification desired.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
-Strong organizational and follow-up skills, as well as attention to detail.
- Ability to maintain regular and predictable attendance.
Company DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.
Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities
Company Description
Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.\r\n\r\nBased in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities