What are the responsibilities and job description for the Senior Manufacturing Quality Engineer position at KYYBA?
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.
Looking for someone well versed in software verification and validation and risk controls/activities and trace matrix.
