Senior Quality Assurance Engineer-Medical Products
Daytona,Fla- The Catalyst Recruiting Group www.catgroupinc.com is proud to be working with a growing medical device/products client in the Greater Daytona, Florida area who is expanding and looking for a Quality Engineer. This position will take responsibility for quality engineering functions within the manufacturing facility by assisting in developing, implementing and administering quality specifications, test methodologies, and sampling plans for product and process. This role will work cross functionally with. This position works directly with manufacturing, R&D and engineering to assure quality is covered in the design, testing, and release of materials, components and completed products. This role will provide quality-engineering expertise for the continuous improvement of product and process and provide engineering input for corrective and preventative action for in-house and customer reported problems. Participation in internal audits, supplier audits, and assessments by external parties is expected. Position is expected to function as a problem solver, capable of analyzing problems and implementing root cause elimination solutions. Position maintains primary responsibility for critical quality systems as delegated by the Quality Manager, which can include the internal audit program, CAPA system, environmental monitoring, and OEM customer support. This position is responsible for assuring overall regulatory compliance to the QSR and applicable Quality System standards. to both product design requirements, internal standards and external standards.
REQUIRED Completed 4 year degree, no exceptions, corporate policy. At least 2 years in an FDA regulated industry in a Quality Assurance function recently in a manufacturing environment; preferably in a high volume, automated manufacturing environment in a regulated industry.
Highly Desired Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) credential desired. Six Sigma or Lean training desired.
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