186 Quality Assurance Engineer
186 Quality Assurance Engineer (186 QAE)
POSITION SUMMARY:
The QA Engineer will be responsible for supporting critical initiatives in quality related support for the life cycle development of Class I, II and III medical devices, including new product development of orthopedic medical devices. He or she will enhance the monitoring and reporting of Quality Assurance and Compliance by enhancing relevant metrics. His or her primary responsibilities will include developing, implementing and improving overall quality systems, including quality standards, test methods, process control techniques, and reviewing documents such as work instructions, Quality Assurance Specifications, Final Inspection Instructions, protocols and reports to ensure safety, reliability and efficacy of new products, processes and significant changes related to existing medical devices. The QA Engineer will also evaluate design quality, validation and trouble shooting activities and assess product configuration, materials compatibility, manufacturing processes and initiate corrective action process to meet and exceed QSR, FDA, ISO and internal standards.
Primary Responsibilities:
- At least 3 years experience in a GMP or QA environment
- Apply Compliance and Quality practices in accordance with US, Japanese, and Canadian regulations.
- Stand as independent QA reviewer along NPI and Customs dossiers.
- Trigger Corrective and Preventive Action CAPA to manage and mitigate safety and/or compliance issues.
- Complete review of custom Design History Files and Design Manufacturing Records.
- Excellent analytical, decision making and problem solving skills along with strong verbal and written communication stills.
- Complete internal and Vendor audits according to company plan.
- Complete QA release of products under ERP system.
Qualifications:
- Bachelors’ in Engineering or equivalent background
- Knowledge of US, Japanese, and Canadian regulations.
- 510(k), IDE, PMA (original/revision/supplements) preparation experience
- Knowledge of regulations applicable to spinal implants and instruments (ISO13485, cGMPs, 21CFR820)
- Working knowledge of FDA and EU Medical Device Regulations
- Direct interaction with FDA reviewers/inspectors
You can email resumes to Admin@LegacyMedSearch.com
ABOUT Legacy MedSearch:
Retained Recruiting Firm specializing in the Emerging Medical Technology. Our firm is hired by medical device and imaging manufacturers to find senior-level executives in specialized fields such as surgery, diagnostic & therapeutic imaging & radiology, including CT, MR, PET, DR/CR, Ultrasound, HIFU, Fluoroscopy, PACS, Mammography, MIS & LIS procedures. We work with manufacturers of a variety of implants & technologies: IMD, AIMD and Class I, Class II and Class III devices with special emphasis on orthopedics, Navigation (IGS, CAS, DBS, Surgical Robotics, NeuroScience), neurosurgery, radiology, neuroscience, cardiology and cardiovascular and other emerging medical technology (VC, PMA, 510(k) & IDE device classes).
Our office recruits: Product Managers, Engineers (Product Development, Design, Manufacturing, Electrical and Software engineers), Marketing and Sales Executives, Operations, Quality, Regulatory, Research Professionals.
In the past 18 months, we have placed 48 professionals in start-up, emerging & leading medical companies. For additional information, please visit our website at www.LegacyMedSearch.com