QUALITY ENGINEERING MANAGER Job
Job Code - 38738
Job First Active on: Friday, January 27, 2012
QUALITY ENGINEERING MANAGER
•Assure all activities are in compliance with Design Controls and the relevant elements of the Quality System Regulations, with emphasis in site and corporate change control procedures for combination products and processes. •Assist in the establishment of a phase gated structured development process for devices and lead the quality work stream activities for product and process development initiatives. •Establish a complaint handling system for returned devices and conduct root cause investigations for internal and external field complaints in a timely and effective manner •Assist in specification development through user studies, design of experiments (DOE’s), and analysis of data using statistical tools and in-depth evaluation of variable factors. Exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results. •Work with cross-functional groups to assist in the development of engineering studies, design verification protocols, stability studies (for device) and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. •Oversee and/or perform measurement systems analysis (MSA’s) for all critical performance test methods •Lead Risk Assessment activities for Application, Design, and Processes •Participate in design reviews and provide expert Quality input. •Assist in the development and adherence to site Validation Master Plans, and execution of Operational and Performance qualifications as well as Process Validations for combination products in accordance with established regulations and approved site and corporate standards and procedures. •Participate in product or process improvements and optimization utilizing Lean and Six Sigma methodologies. •Participate in supplier, customer and/or regulatory agency audits.
REQUIREMENTS - QUALIFICATIONS: QUALITY ENGINEERING MANAGER
•BS degree in Mechanical Engineering or relevant engineering discipline. Advanced degree a plus. •Minimum of 7 years of quality engineering experience in the Medical Device, Pharmaceutical or Biotechnology industry •Strong analytical, technical writing, verbal communication and interpersonal skills • Thorough knowledge of quality systems, validation principles for product and manufacturing processes, engineering design fundamentals, • Thorough understanding of regulations, familiarity of regulatory environment and industry trends for combination products •Working competency of statistical programs (i.e., Minitab, SAS, etc.) •Certified Quality Engineer (CQE) preferred •Certified Six Sigma Green/Black Belt or equivalent preferred
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