What are the responsibilities and job description for the Engineer, Software Quality position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Develop and conduct training of company personnel for the divisional software development and validation program.
- Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation 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. 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.
- 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. 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 travel including internationally. Ability to maintain regular and predictable attendance.
