| Manufacturing Validation Engineer - ONSITE - Junior Candidate at Junior, West Virginia, USA |
| Email: [email protected] |
| From: Devakar, KK Software Associates [email protected] Reply to: [email protected] NO OPT and CPT JD: Technical/Functional Skills 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 ISO13485-2003 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. Microsoft Office Suite and Project Experience Required 2 - 4 years Roles & Responsibilities 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. Keywords: rlang |
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| Thu Sep 21 19:55:00 UTC 2023 |