Quality Systems Analyst II
| Company | Jabil |
|---|---|
| Location | Elkton Dr, Colorado Springs, CO, USA |
| Salary | $79400 – $143000 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level, Senior |
Requirements
- Bachelor’s degree required and 4-8 years related experience; or equivalent combination of education and experience.
- Advanced level of experience in use of personal computers, with Microsoft Office applications (Excel, Word, PowerPoint) and email skills required.
- Ability to effectively present information and respond to questions from groups of peers, stakeholders, managers and customers.
- Familiarity with data formats such as JSON, XML, or CSV.
- Understanding of SQL or other data querying languages, and familiarity with Python for data manipulation.
- Ability to understand and apply basic statistics concepts, such as probability distributions and hypothesis tests.
- Experience working with structured data.
Responsibilities
- Drive the execution and transformation of Quality Systems (QS) at site level, including Computer Aided Quality (CAQ) systems.
- Oversees ERP issues, procedures, and understanding.
- Works with the organization’s stakeholders, as well as interfacing with suppliers and customers, to ensure Quality System initiatives are progressed and issues resolved.
- Support site readiness in the deployment of these QS initiative.
- Support compliance and continuous improvement of the Quality System.
- Support document control area where needed.
- Supports the deployment (design, implementation, and post-monitoring) of process initiatives impacting the site that promote the continuous improvement of the QS.
- Manage or Perform UAT for new projects/normal daily basis tickets being implemented.
- Oversee applicable management of SAP IT, Service Now ticket resolution for the site tied to QS software.
- Oversee and collaborate in execution of mass loads for router and BOM updates.
- Develops competency of resources at the site related to CAQ Software and change management by providing training and guidance on the execution and documentation.
- Execution and support for CAPAs, NCs, and Observations related to site-specific QS.
- Supports compliance activities by participating in audit readiness; assisting in Internal and External audits; serving as Subject Matter Expert; supporting the investigation, response, and remediation of site-specific QS audit observations.
- Coordinate on site Document Control (as required), including management of change documentation, on-site administration of the change control system, and archival of documents on site.
- May perform other duties as assigned and not all responsibilities may be assigned.
Preferred Qualifications
- Experience in medical device manufacturing including ensuring requirements and regulatory compliance within FDA Title 21 CFR Part 820 & ISO 13485.
- Experience in computer aided quality processes.
- Experience in identifying and leading process improvement projects.
- Experience with nonconformance, CAPA, Audit observations.
- Experience in statistical analysis.
- Experience with root cause investigation techniques such as 5 Why, Fishbone, Is/IsNot.
- Experience in periodic review and maintenance of relevant quality documentation files.
- Experience in quality documentation Change Management initiation and resolution.
- Proficiency preferred in use of EtQ reliance software, BabtecQ Inspection software, Windchill Change Management software, ComplianceWire Training software, Critical Manufacturing MES software.