Langley Group
Langley Group

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Other Service Line - GeoSpatial Sr.Analyst MAP - GSSANL

Tech Digital Group

Warsaw, IN • On-site

Contractor

Re-posted 16 days ago


Job description

Top 3 MUST have skills.
1.Strong Medical Domain Experience
2. Exposure to ISO13485 and ISO14971 medical standards and have exposure to risk
3. Responsible for IQ/OQ/PQ methodologies and report generation.
Job Summary:
End to end support of Manufacturing process validation.
validate the manufacturing process
Perform statistical analysis to prove the manufacturing process capability
Support in overall delivery of the project.
Responsible for verifying and validation of several machines and various process involved in it.
Responsible for IQ/OQ/PQ methodologies and report generation.
Experience: 7 to 8 Yrs.
Required Skills: Labelling, Medical device development
Shift: 9am to 7pm EST
Roles & Responsibilities:
KEY COMPETENCIES REQUIRED
Bachelors Degree in Engineering
Exposure to ISO13485 and ISO14971 medical standards and have exposure to risk
Manufacturing Engineer
End to end support of Manufacturing process validation.
validate the manufacturing process
Perform statistical analysis to prove the manufacturing process capability
Support in overall delivery of the project.
Responsible for verifying and validation of several machines and various process involved in it.
Responsible for IQ/OQ/PQ methodologies and report generation.
Preparing document in business process by identifying the business requirements.
Understanding functional specifications and system design specifications for client engagements.
Analyse issues recurrence to identify patterns and gaps identification, drive root cause
analysis, and translate findings into solutions to improve workflows, processes and tools
Interaction with manufacturing and design team to identify improvement areas in manufacturing process
Interaction with supply chain management team related to manufacturing activities
Implementation and follow the operational standards, policies and procedures.
Optimization of manufacturing processes and methodologies
Mitigate risks reported during the project
Documentation of process change in engineering change management system
Job Location: Warsaw - IN
Job Type: 60CW00 Business Associate
Demand Requires Travel

N
Certification(s) Required: NA Years of Experience: 14.00 Years of Experience