Process Quality Engineer / Validation Engineer

Process Quality Engineer / Validation Engineer 
Until the year end
Eugene OR

Validation of production/manufacturing processes
• Validation of test methods and test equipment
• Calibration of measurement equipment
• Software validation of non-product software systems utilized as part of the Quality Management System
• Author receiving inspection plans for procured materials
• Support labeling production processes and implement appropriate controls to ensure correct label content and label integrity
• Work with manufacturing to improve the content of Device History Records
• Creation of quality documentation and development of SOPs for their facility and products in line with industry standards
• Proactive review and improvement of systems and processes to ensure the maintenance of standards
• Maintaining accurate quality documentation
• Working closely with manufacturing staff to ensure quality protocols are followed and documentation is correctly maintained and implement any new changes or adaptations based on a quality review. Review designs, changes, and plans of specifications and processes.
• Inspection and testing of various parts of manufacturing including products, components, processes, and comparing against predefined standards
• Ensuring safety requirements are met at every point in the manufacturing facility
• Analyzing problems reported and developing improvements to overcome them
• Statistical analysis of manufacturing data and creation of reports for senior staff members based on quality documentation
• Working closely with external partners e.g. suppliers, customers, etc
• Continuous improvement in the manufacturing process
• Oversee tests and monitor activities such as software configuration verification
• Evaluate software and run tests
• Oversee code verifications and participate in peer reviews
• Ensure project and processes meet all requirements and reliability standards
• Modify and maintain software quality operating systems
• Work with product managers, developers, and operations teams to prioritize tasks and workflow
• Perform code reviews and participate in pair programming
• Collaborate with team to identify and implement process improvements

Education and Training:
• Bachelors degree required
• ASQ Certifications desired
• Minimum 3-5 years experience in a medical device manufacturing environment

Competencies:
• Quality regulations and standards
o 21 CFR 820
o ISO 13485
o EU MDR
• Analytical skills – need to be able to spot problems quickly and find the underlying causes
• Critical thinking – once problems are identified, solutions and improvements shall be implemented
• Attention to detail
• Numerical skills – statistical analysis is required in this role
• Communications skills – strong written and verbal communication skills are key. Must be able to relay potentially complex ideas to a wide range of audiences – both in personal consultations but also through company SOPs and quality documentation


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