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Job: Quality Assurance Technician (Med Device/Clean Room) – Direct Hire/Top $$, Frankel Staffing Partners, RTP, NC
Quality Assurance Technician (Med Device/Clean Room) – Direct Hire/Top $$
RTP, NC 27709 United States
Our client, an RTP area medical device company in high growth mode, is actively recruiting for skilled, knowledgeable and self-directed candidate to assume key role on its Quality team.
Company will pay excellent wage to attract and retain an excellent candidate.
This company is producing novel, cutting-edge products in the cardiovascular space and is preparing for several commercial launches. These products are implanted into humans and it is essential that every product is impeccably manufactured. This Quality Technician will be critical to that effort.
This is a diverse role that will involve the Quality review of all stages of production – from raw materials to completed product. It will also involve ensuring timely and compliant documentation. Seek candidate who is skilled in all, and understands the importance of GMP-compliant documentation. Further, this is a clean room setting and expertise in clean room manufacturing is required.
• Assess the condition of product, from its raw material stage to being a completed product, to ensure it is not damaged or have any defects
o Perform visual, dimensional, and functional inspection of product and components per procedure, specification or drawings using measuring equipment (i.e. caliper, micrometer, tape, height gauge, etc.)
• Provide clean room support during manufacturing builds, including participation in area/line clearance, documentation oversight, confirmation of manufacturing documentation and reconciliations
• Conduct Quality review of product labeling including barcodes, lot numbers and WIP labels
• Reconcile manufacturing documents (batch records) with finished parts inventory
o Perform documentation reviews of Device History records, inspection and test results
• Confirm maintenance and calibration of equipment (i.e. gauges, balances, etc.) is current or removed from service prior to the due date
• Collect data (manufacturing data and yields, testing, production, etc.)
• Perform failure and routine analysis
• Audit materials, processes and documentation
• Assist in the investigation/resolution of Non-Conforming materials and product-related issues.
• Provide support to the Quality Assurance department in the performance of investigations on reported product failures, adverse events or field complaints
• Update and create Standard Operating Procedures for Quality System related activities.
Targeted candidate will offer a related degree and 5+ years of Quality experience in medical device manufacturing or other directly-related Life Sciences industries. Background handling all/most functions noted above will be required. Other priorities include:
• Clean room experience and production manufacturing experience.
• Knowledge of ISO, FDA and Quality System Management concepts and guidelines
• Strong organizational, project management and communication skills
• Strong commitment to continuous improvement
• Longevity and impact in previous positions
Finally and critically, we seek a flexible, versatile and get things done team player. This is an emerging company with a highly dynamic setting. Priorities shift regularly and disruptions occur frequently. Seek focused and adaptable candidate who will work exceedingly well in this building setting. Growth potential is enormous.
This is an immediate need. Please forward Word resume for prompt consideration.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.
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