Manufacturing Engineer
Company: HCL Technologies
Location: Warsaw
Posted on: June 23, 2022
Job Description:
- Develop and execute all the Process Validation deliverables /
activities which include IQ, OQ, PQ, SOP, Validation Plan,
Functional Requirement Specifications (FRS), User Requirement
Specifications (URS), Requirement Traceability Matrix (RTM) and
summary reports.
- Perform capability analysis (Cpk, Ppk) on test data,
investigate outliers and work on sampling plans (Minitab).
- Perform Design Of Experiments (DOE) to determine sampling
plans.
- Develop Test Method Validations (TMV's) using the principle of
Gauge R&R, testing methodologies
- Collaborate with cross functional teams for various projects
following Quality Management systems in compliance with ISO 13485,
21 CFR 820,
- Utilize fundamental Engineering to apply Lean, Kaizen and Six
Sigma in the improvement process.
- Prepare detailed project plans with breakdown of all
activities, milestones, efforts, and timeline in concurrence with
project members & stakeholders
- Monitor and evaluate project resource needs ensuring the
continuity of project and timely communication to stakeholders
- Track project milestones, organize weekly governance meetings,
and provide regular status reports
Keywords: HCL Technologies, South Bend , Manufacturing Engineer, Engineering , Warsaw, Indiana
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