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
Role: OKTA Security ConsultantDuration: 6-12 monthsRemoteRole Overview:An experienced and highly skilled Okta Certified Security Resource is sought to join a growing security team. This individual will be critical in designing, implementing, maintaining, and optimizing...
...with additional hours/times as needed in Aventura, FL. No hybrid or remote. About the Role The Network Administrator Cisco Meraki IoT will own the architecture, implementation, and lifecycle management of CTTIs Cisco Meraki SD-WAN, campus switching, Wi-Fi...
...Description Job Overview: We are seeking a dedicated Infant and toddler one year old Lead Teacher to join our team at a Christian Preschool. The ideal candidate will have experience working with Toddlers or Two year olds. Must possess strong classroom management skills....
...A full-time Social Worker is needed to support K-12 students in a Washington, PA school district. This contract position offers a 37.5-hour workweek... ...through Friday. The primary caseload will focus on middle and high school students, with occasional responsibilities at the...
...Job Description Job Description Job Summary: Established 3PL seeking a motivated and experienced FTL/LTL Freight broker with existing and potential client relationships to join our elite, customer centric team as an independent contractor. 50% of your net. Yep....