For Quality Engineering services in the Process Development area.
What Makes You a Fit:- Bachelor’s Degree in Engineering and 5 years of experience in the review and approval of life cycle validation documentation in the regulated industry.
- Bilingual: Spanish and English.
- Soft Skills: Attention to detail, organization, and writing skills.
- Shift: Administrative, and according to the business.
- Experience:
- Process and/or equipment validation activities (IQ, Characterization, OQ/PQ).
- Develop Master validation plans for new processes or products.
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your many talents. Being the Piece means you’re full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?
As a Piece of Fits, You Will (Day-to-Day on the Job):- 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.
- Identify and control 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.
- Develop process monitoring systems by identifying critical process steps and applying methods to reduce process variation to reduce/eliminate the cause of defects.
- Lead 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.
- Assist 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.
- Evaluate the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the client's quality system, such as development and manufacturing, as assigned.
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