Job Details
This is an onsite role, remote work not possible.
Pay $50-53/hour W2.
W2 Candidates only for this role, C2C not possible.
Description
- This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for softare utilized throughout Client.
- Develop and conduct training of company personnel for the divisional software development and validation program.
- Engineering in the completion of system/software requirements and other verification and validatiton processes.
- Create and execute or direct software validation protocols traceable to system/software requirements.
- Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
- Assist in the completion and maintenance of risk analysis, focused on software related risks.
- Design and implement various product and process improvement methodologies (i.e, Six Sigma and Lean Manufacturing).
- Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues.
- Software scoping and Part 11 audits.
- 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.
- 2-5 years Software Quality Engineering experience.
- Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485.
- Advanced computer skills, including statistical/data analysis and report writing.
- Advanced Information Technology and data mining skills.
- Prior medical device experience preferred.