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Director of Quality - Medical Device
$180,000.00 - $220,000.00
Master of Science; Bachelor;
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Site Director of Quality - Medical Device Operations
The Global leader in the development and production of surgical medical devices seeks a Site Director of Quality to lead all quality activities at one of the company's manufacturing sites in New England USA. The Quality Director will lead a quality group of more than 30 indirect reports with three direct reports. This site has approximately 450 non-union full time employees. The Site Director of quality reports to the VP of Quality for this Division of Products in this multi-billion dollar Corporation.
Director of Quality Responsibilities include:
Own the Quality System and Quality Strategy for this product portfolio, current and new product development for all manufacturing and global distribution of medical device product, ensuring that short and long range quality strategy, plans, goals, annual operating plans and budgets are aligned with the business.
Serve as the “Management Representative” as prescribed in the Quality System Regulation (QSR 21 CFR 820), ISO 13485:2003, Canadian Medical Device Regulation (SOR/98-282) and EU Medical Device Directive (EU MDD 93/42/ EEC).
Create and implement process improvement programs and projects
Lead and Manage a top-performing team of Quality Managers and Engineers; mentor, train, and coach Develop in-process and finished product inspection data, providing trend analysis and improvement opportunities
Ensure quality product is available to customer through new product design, design review, engineering, customer/vendor relations, manufacturing quality, cost reduction, inspection, environmental monitoring, calibration, training, product sterilization, customer complaints and MDRs.
Develop and implement systems that monitor the Quality Management System (QMS) and report to management periodically on audit results, corrective action and performance. Recommend and drive improvements. Follow up and support of employees and teams to ensure corrective actions are initiated, implemented and measured for effectiveness.
Manage and operate effectively in a highly matrixed organization while fully supporting cross-functional initiatives in the areas of quality.
Oversee customer complaints, resolve complaints and return products investigations and analysis
Requirements for the position of Site Director of Quality - Medical Device
Bachelor's degree; preferably in an engineering or technical discipline, MS in Quality Preferred
10+ years of Quailty System Experience experience; must have FDA Class I, Class II or Class III experience ; most products are class III at this location
5+ years QA experience medical devices including management of others; Biotechnology Quality compliance may be a fit as well.
A candidate should be a Quality Director within manufacturing currently or Vice President of Quality (depending on size of organization) and should have strong leadership, examples of implementing strategy and change and be ready to promote to Vice President roles in the next 2-4 years within a large global Medical Device company with over 85 locations WorldWide.
Must have 3 or more years' experience in a large Matrix Global Organization in an executive Senior Management or Director level role.
Some Experience as point of contact or lead for FDA audits, EU, JPAL etc.
Audit experience highly desired
Strong working knowledge of FDA regulations ISO 13485, ISO 14971, MDD, 21CFR820, MDR, MDD 93/42/EEC- required
Experienced with root cause analysis and failure investigation
ASQ Certifications preferred
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