| Validation Engineer at Remote, Remote, USA |
| Email: [email protected] |
| From: Tanul, 3b staffing [email protected] Reply to: [email protected] Role: Validation Engineer VIsa : USC or GC or GCEAD or H4EAd or OPY REMOTE Skills - ISO 13485 or ISO 21CFR part 11, Validation and Verification, Root Cause Analysis, write and test protocols, writing procedures Required Qualifications: Excellent quantitative and analytical skills Ability to prioritize tasks in a fast-paced environment Strong written and oral communication skills required Proficiency in Microsoft Office (Word, Excel, PowerPoint) Responsibilities: Assist in the maintenance of an effective Document Control Management system, including relevant Standard Operating Procedures (SOPs) and Work Instructions (WIs) for the proofing, filing, copying, scanning, archiving, retrieval, and maintenance of all controlled documents and records required by applicable regulations. Manage the Quality Assurance Processes to be followed in the event of a complaint, deviation, CAPA, recall or field action per 21 CFR 803, 806, 820 and ISO 13485. Coordinate and participate in investigations. Ensure adequate follow-up through the implementation of corrective and preventative actions (CAPA) as required. Manage the risk assessments and follow-up activities and ensure visibility for potential risks. Monitor and audit recall/field action activities to assure compliance with Standard Operating Procedures related to corrective actions, CFR requirements and customer complaints. Strengthen quality awareness throughout the organization, support technical services and process improvements. Eliminate barriers and proactively investigate quality issues using appropriate process improvement and problem solving techniques. Develop and maintain quality-related training programs and ensure implementation to minimize business risks. Provide Quality support to members of leadership team especially during audits and inspections as part of the audit team. Ideal candidate will be able to lead internal audits. Ensure that QA activities are properly staffed, operate in a cost effective manner, and maintain an innovative approach based on productivity improvement and implementation of best practice. Work with Manufacturing and R&D to ensure that products are developed and produced according to applicable regulations and standards. Ensure timely product disposition in compliance with all applicable regulatory and legislative requirements. Maintain database(s) or spreadsheet(s) for the worldwide regulatory status of products. Assist in the development and implementation of regulatory strategies and prepare FDA (IDE, 510k, PMA, 513G) and international submissions (CE Mark, TGA, CMDR, etc.) for new products and product changes as required to ensure timely approval for market release and in accordance with applicable regulations, standards, and guidance. Maintain systems for labeling, promotional material, change control, and the documentation for these systems as required by domestic and foreign governments. Monitor industry and regulatory trends to develop strategy and provide guidance related to these trends. Advise technical, marketing, and sales personnel on regulatory requirements (e.g. Design Controls, CE Marking, IDE, IRB, Labeling, and Promotion). Desired Qualifications: Knowledge of 21 CFR 803, 806, 820, ISO 13485 and all applicable requirements and regulations to support the manufacture and distribution of medical devices Medical Device Experience Keywords: quality analyst rlang container edition green card Validation Engineer [email protected] |
| [email protected] View all |
| Fri Jun 07 00:11:00 UTC 2024 |