169 QA CQA Auditor Compliance Associate
169 QA CQA Auditor Compliance Associate (Job ID 169 QAA)
Position Summary:
The successful candidate will work to ensure QA compliance for a major global medical device company. YOU MUST HAVE A CQA DESIGNATION in order to qualify for this position.
Responsibilities:
- Responsible for maintenance of pertinent standards including but not limited to: 21 CFR Part 820, ISO9001:2000, MDD, ISO13485:2003, Canadian Medical Device Regulation
- Write, revise, manage and review SOP from a QA perspective
- Using your expertise in QSR quality systems and quality techniques, perform/assist in internal assessments by collecting and analyzing accurate and objective evidence
- Using your high level of expertise in current regulatory requirements and technical issues, participate in QA/QC multi-site projects in the roles to include contributor, coordinator or leader
- Assist in the training of staff and assure that physician and staff training requirements are met and records are up to date.
- Use your knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices to assure company stays in compliance with QSR.
- Participate in FDA and ISO audits and QSR Regulatory Assurance as required.
Educational Requirements:
BA/BS Degree in business, engineering, life science, engineering, quality or regulatory compliance or related areas
Required Experience:
- 3++ years experience in Quality Assurance or QC/QA analysis.
- Knowledge of FDA and ISO regulations regarding RA/QA regulations and knowledge of scientific strategies and new methods or new avenues of investigation.
- Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices- Excellent proven interpersonal skills in dealing with all levels of professionals.- Proficiency in the use of PC and programs, particularly Excel, Word
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