Quality Engineer

Company: Katalyst Healthcares & Life Sciences
Location: Spartanburg
Posted on: July 31, 2022

Job Description:

Job Description Responsibilities: Support/lead ME/PE to implement/maintain, as a team member, Process flow charts, Process Control Plans, Process FMEA, validations. Support transfer from NPI to high volume manufacturing and develop quality control plans Responsible for issuing or reviewing and approving validation documents related to gamma irradiation and product sterility claims Coordinate validation activities & development of analysis methods with laboratory contractors Ensure supplier qualification (during the NPD process): prepare, perform and follow up on supplier audits. Manage POR processes; assure root cause analysis and effectively implement robust CAPA. Follow-up and verification of CAPAs to assure no recurrence. Facilitate the closures of NCRs in a timely manner Manage and maintain overview of all external customer complaints (Daily management in OBEYA PPM reduction) Manage CAPA processes; assure root cause analysis and effectively implement robust CAPA in a timely manner. Follow-up and verification of CAPAs to assure no recurrence. Adhere to corporate escalation and reporting guidelines Implement continuous improvement practices, including appropriate kaizen events on relevant Quality processes. Support Shin Kaizen events and use Lean manufacturing principles, as and when required. Roll out CDT, VOP, DRS, PSP, FMEA- utilize DBS to drive continuous improvements. Provide Manufacturing Quality Trend Charts/Analysis and suggest/implement improvements based on the trends. Support Supplier Quality Engineer for driving improvements for Supplier related issues (SCARs), work closely with Purchasing / SS to select/maintain/drop Suppliers list based on their performance Support QMS to meet ISO 9001 requirements; identify and implement/maintain specific standards to QMS Perform Internal Audits per the annual audit schedule, prepare report, follow-up and verification of completion of actions initiated from audit(s) Works closely with Sales, R, and Manufacturing to optimize the company's products and relationships with our customers including technical presentations at Customer sites. Support responses to customer questionnaires, certification requests and surveys; prepare and maintain/update standard responses/data for use by Customer Service Support customer audits and be the quality contact for customer and supplier questions regarding sterility, POR, SCAR, validation and deviation. Implement, maintain and monitor change control and customer notification procedures Accountable/Responsible for maintaining Quality KPI's; drive improvement(s) to continually improve the goals/KPIs Is the go to point when non routine quality issues occur

Keywords: Katalyst Healthcares & Life Sciences, Spartanburg , Quality Engineer, Engineering , Spartanburg, South Carolina