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Manufacturing Validation Engineer - Warsaw, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities:
Experience in supporting medical device manufacturing.
Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ
Validation Experience, especially cleaning
Processes experience, molding, cleaning, packaging
Specific experience with Test method Validation and Gage R&R
Experience with root cause analysis and problem-solving for both technical and process issues
Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO
Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner.
Good problem-solving skills through the use of quality and statistical tools, Six Sigma
Ability to read and understand engineering drawings.
Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ) Analysis
Knowledge of Quality System requirements, ISO and FDA requirements
Ability to effectively work within a cross-functional team to complete critical project tasks.
Demonstrates good written and verbal communication skills.
Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions and proficient with Statistical Process Control concepts, process development, CNC programming terminology, and tooling design concepts.
Requirements:
supporting medical device manufacturing
Process characterization, equipment IQ/OQ, process OQ, and PQ
Test method Validation, Gage R&R
Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers.
Supporting a wide variety of processing applications such as machining, finishing, molding, cleaning, heat treating, bonding, molding, etc.
Conducting feasibility studies to estimate a product cost and analyze capital equipment, capacity, and capability requirements.
Establishing and improving process methods that meet performance and quality requirements.
Developing and executing project plans and schedules for work activities
Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.
Evaluating multiple options to select the most appropriate processes and machining methods.
Execute equipment qualification and process validations.
Minimum B.S.
degree from an ABET-accredited school (or global equivalent) in one of the following engineering disciplines, 2-4 years of experience: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering.
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