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Develop, implement, and maintain Quality System requirements on assigned areas of Manufacturing and Process Validation / Process Verification. Areas of responsibility may include: Non-conforming product, CAPA, Calibration Systems, Measuring techniques, Design of tools and gages, Training, Statistical Support, Quality Planning, Experimental Protocols, Facilitation of Root Cause analysis, Risk Assessment and Complaint Investigation.
ENGINEERING DUTIES AND RESPONSIBILITIES:
• Leads engineering projects that are less complex, either technically or with a small cross-functional team. Leads and participates in projects including developing and executing to the plan and schedule and meeting the goals and objectives of the project. Prepares status reports, conducts meetings, and documents and communicates progress to management.
• Leads and participates in investigations, develops plans and executes tasks to solve process problems including Non-conformances (NC), complaint investigations, audit observations and Corrective and Preventive Actions (CAPA).
• Provides day to day support and direction to production such as nonconformance support and other frontline responsibilities
• Provide process validation program oversight to ensure adequacy of validation activities and documentation in terms of regulatory compliance and technical/statistical soundness.
• Review engineering studies, process validation protocols, and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
• Provide guidance to others for the generation of clear, concise and defendable protocols and reports.
• Identifies and implements process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies such as, Lean and Six Sigma principles.
• Performs gage design, measurement system analysis, and gage implementation as required. Is able to use various types of measuring instruments including, micrometers, calipers, comparators, tensile testers, coordinate measurement systems etc. to support engineering testing.
• Member of the Material Review Board (MRB). Communicate and resolve quality issues and apply root cause analysis to drive corrective and preventive actions.
• Develops and implements inspection procedures.
• Participates in, and, in some cases, leads cross-functional teams which may include, but are not limited to Manufacturing Engineering, Production, Quality Assurance, Finance, and Product Development.
EDUCATION AND EXPERIENCE REQUIREMENTS:
• Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
• 2-4 years of experience in medical device manufacturing and/or engineering is required.
• Previous experience working in a regulated industry, such as Medical Device is required.
• Strong Statistical ability and experience including Gage Repeatability and Reproducibility, Statistical Process Control, Process Capability and Design of Experiments.
• Demonstrates strong written, verbal and presentation skills.
• Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.
• Demonstrates strong organizational and project management skills and are results oriented.
• Demonstrates positive interpersonal skills and professional interactions with coworkers.
• Working knowledge of Geometric Dimensioning and Tolerancing, Blueprint Reading, Basic Metrology, Gage design, Design/Process FMEA and Quality Plan Development.
• Participates in and understands compliance related activities pertaining to the job assignment including compliance with the Quality System Regulation (QSR), Standard Operating Procedures (SOP), and applicable Work Instructions.
• Follows all laws and policies as they apply to one's job and maintains the highest levels of professionalism, ethics and compliance at all times.
• Supports and operates in a proactive safety environment
• Works in conditions that may be hot, cold, wet and/or noisy along with exposure to fumes, oil, coolants and other manufacturing related chemicals.
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