Description :
This is a direct leadership position in a major, state of the art medical device manufacturing facility and may serve as the Deputy Quality System Management Representative in the absence of the Quality Manager/Director. This position works directly with Manufacturing, R&D and Engineering to assure quality considerations are adequately covered in the design, testing, and release of materials, components and completed products. Position is expected to have an expert level understanding of FDA regulations and ISO 13485 , MDD and CMDR requirements; 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 -- develop, implement and administer quality specifications, test methodologies, and sampling plans for products and processes. Position maintains primary responsibility for critical quality systems as delegated by the Quality Manager, which can includ e 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. MINIMUM REQUIREMENTS : Education: Bachelors degree in a technical field, Engineering preferred. Experience: 7+ years in an FDA regulated industry in a Quality Assurance function . Supervisory experience preferred . Preferred Skills/Qualifications: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) credential desired. Six Sigma or Lean training desired. Skills/Competencies: Expert Level knowledge of quality systems, ISO 13485:2003 and FDA 21 CFR Part 820 .