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