Senior Quality Engineer

Business Title: 3076 Senior Quality Engineer Location: Sturtevant, WI 53177 Job Type: Contract (6 M+) Job Description: This position is responsible for providing Quality Engineering and Technical Support for Operations, Sustaining Engineering, R&D, and New Product Introductions. This position would include supporting a wide array of activities related to Change Control, NCR/CAPA, Quality Operations, Design Control, New Product Development, Risk Management and Post Market Surveillance. This position would evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are needed. Provide direct support to Quality personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed. Job Responsibilities: Change Control: Review change requests and identify impact on product design and documentation Support Change Control Activities (Operations, Engineering, Design, etc.) Support updates to manufacturing procedures, process, product / specifications, risk management files, etc. through the Change Control process Support 3rd party supplier management activities such as review 3rd party design control activities Design Control/Documentation: Review documentation for technical accuracy and compliance to procedures Review Technical Writing and Documentation Support operations, sustaining engineer, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products Quality Initiatives: Provide quality engineering support for supplier changes and resolution of issues at suppliers Identify new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies Work with manufacturing and other functional groups on manufacturing regulatory compliance issue Support training program by delivering assigned training tasks Support NCR and CAPA: Support / lead corrective/preventive actions and product non-conformances including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting Risk Management: Support Risk Management activities including review and coordination of quality activities related to risk Inspections: Support with federal, state, and local regulatory officials during regulatory inspections Support in internal and vendor quality system audits as applicable Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) and non-EMD medical devices Skills & Experience Required: Bachelor's degree in relevant field 3-5 years Quality Engineering Role 6-7 years Medical Device or Pharmaceutical Industry or similar experience ASQ Certification as a Quality Engineer or equivalent preferred Understanding of system software, firmware, and hardware integration Familiarity with statistical sampling requirements for Design Verification and Process Validation Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations