Quality Engineer – Process Development

Weil Group•Dorado, PR

About The Position

We are looking for qualified Quality Engineer that develops and reviews documentation and procedures, and provides automation systems testing and validation in support of Process Development and/or Manufacturing Process Engineering.

Requirements

Develops and reviews documentation and procedures
Provides automation systems testing and validation
Support process and/or equipment validation activities (IQ, Characterization, OQ/ PQ)
Develop Master validation plans for new processes or products
Review process validation protocols and reports
Support other functional areas during the validation activities
Collaborate with the Process Development team
Assist on statistical sampling plans, and other development procedures
Design and develop in-process and receiving quality systems for new processes and components
Define gages, tools and equipment for the test methods developed
Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints)
Participate in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions
Query & bound data to support implementation of complex & document release criteria
Create risk analyses and FMEAs
Develop Process Monitoring Systems by identifying critical process steps
Apply methods to reduce process variation to reduce/eliminate the cause of defects
Lead process improvement efforts by identifying methods to capture quality metric data
Perform appropriate analysis methods to enhance sustaining product design and new product development
Assist in creation of Quality Tools & Training Materials
Understand the limitations of existing quality tools and training materials
Identify more effective tools & materials
Evaluate the adequacy and compliance of systems, operations, and practices against regulation and company documentation
Serve as auditor of areas of the Client quality system, such as development and manufacturing, as assigned
Demonstrate a primary commitment to patient safety and product quality
Maintain compliance to the Quality Policy and all other documented quality processes and procedures
Assure that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the Client's Quality Policy
Establish and promote a work environment that supports the Quality Policy and Quality System

Responsibilities

Support process and/or equipment validation activities (IQ, Characterization, OQ/ PQ); process performance qualification activities and develop Master validation plans for new processes or products.
Responsible for reviewing process validation protocols and reports. Support other functional areas during the validation activities.
Collaborate with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures.
Design and develop in-process and receiving quality systems for new processes and components.
Define gages, tools and equipment for the test methods developed.
Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.
May be responsible for creating risk analyses and FMEAs.
Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation to reduce/eliminate the cause of defects.
Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.
Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the Client quality system, such as development and manufacturing, as assigned.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the Client's Quality Policy.
Establishes and promotes a work environment that supports the Quality Policy and Quality System.