Job Description

Siri InfoSolutions, Inc. is a private equity consortium firm providing IT staffing services to Fortune 500 clients across the US. We believe that it’s an exceptional company - a company of people proud of the work they do and the solutions they provide. By understanding what drives our specialty industries, becoming involved in our communities on a professional and personal basis, following a disciplined process of identifying quality candidates, partnering with employers to understand their core business and their employment requirements, and delivering exceptional service, we achieve great results for all concerned. Professional Services: - Contract Staffing - Direct placements - Bench Sales - Application Development - Enterprise Resource Planning - Data Warehousing - Customer Relationship Management Siriinfo provides services to a wide spectrum of customers across verticals such as Banking, Financial Services, Healthcare, Human Resources, Telecom, Insurance, Hospitality, Retail & Distribution and Manufacturing. Serving multinational customers. Siri InfoSolutions reinforces its belief that the quality of our services can only be measured by the skills, performance and dedication of our employees. We will place only the very best candidates for our clients - candidates who are not only willing, but who possess the necessary skills to do the job effectively.

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Job Description

Role: Manufacturing Engineer
Location : Warsaw, IN
Duration : 6 Months

Job Description

• Experience supporting medical device manufacturing Process Validations Specific experience with process characterization, equipment IQOQ, process OQ, and PQ Specific experience with Test method Validation and Gage RR 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 using quality and statistical tools BOM Router creation and update 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 Proficient with Statistical Process Control concepts Microsoft Office Suite and Project.

Roles & Responsibilities:

• Develops and Executes Process Validation Strategies Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective processes for medical devices and equipment.
• Ensures Regulatory Compliance Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge.
• Analyzes Data and Reports Findings Compiles and analyzes validation data, writes comprehensive reports, and identifies trends for process improvement.
• Collaborates Cross-Functionally Works with Manufacturing, Quality Assurance, Engineering, and other teams to implement cleaning strategies, resolve issues, and provide technical support.
• Leads continuous improvement initiatives, manages change controls, troubleshoots cleaning problems, and ensures proper documentation and training.
• 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, forging, casting, cleaning, heat treating, bonding, molding, etc.
• Conducting feasibility study to estimate a product cost and analyse 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 or process validation project(s).

Additional Information

All your information will be kept confidential according to EEO guidelines.

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