Sr. Quality Engineer

This position is responsible for providing engineering and technical support to the Quality Department. This position would support a wide array of activities related to Software Quality, Change Control, NCR/CAPA, Product Surveillance, New Markets and Risk Management. This position would be the lead quality support for design control activities. 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 indicated. Provide direct support to Quality personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed.
Major duties
Software Quality -Originate, review, and approve Software Quality Systems processes and operating controls in accordance with global industry standards, regulations, and requirements (Design, Risk, Validation, CAPA, etc.).
Change Control activities -Originate, review, and approve internal operating procedures and specifications through the Document Change process
Support NCR and CAPA activities -Corrective/Preventive actions and product non-conformance control 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.
Support Product Surveillance activities -Support Product Surveillance through review and ownership of data/trend evaluations and investigations associated with product and patient complaints, analyzing the data for the reasons of Quality Improvement and reporting.
Support New Markets activities -Support New Markets activities including: management of new markets samples process, coordination between new markets group in Germany and WI Tech Ops to manufacture samples, filing of applicable new markets documentation in the Design History File (DHF)
Support Risk Management activities - Lead Risk Management activities including: data preparation for annual product risk file review, review internal documents (IFU, CER, etc) for annual product risk file review, management and preparation of event-based reviews, review and coordination of quality activities related to pFMEA risk matrices.
Supports Internal and Vendor Audit Functions -Supports Internal and Vendor Audit Functions as needed.
R&D Support -Be the lead quality team member to R&D department in the development and validation of new products.
Process improvement initiatives -Coordinates process improvement initiatives for the Quality Department
Adherence to regulations -Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices.
Other duties as assigned- Provides support to Quality Management personnel and perform other duties as assigned.
BS in a Physical Science or Engineering, or equivalent experience required. Required
ASQ Certification as a Quality Engineer or equivalent. Preferred
BS Engineering -Preferred
Professional experience
Experience with electro mechanical device software and hardware validation. Required
Knowledge, skills and abilities (incl. languages)
Knowledge of regulatory requirements for medical device / pharmaceutical organization. Required
Strong technical and general problem-solving skills required; experience with NCR/CAPA processes. Required
Computer skills in Microsoft Word, Excel, PowerPoint, Visio and Access; Adobe; and Quality System Management Software. Required
Experience in performing internal and/or supplier audits. Preferred
Knowledge of methods
Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations. Required
Understanding of IEC 62304. Required
Understanding of system software, firmware, and hardware integration. Required
Medical Device Risk Management regulation ISO 14971 . Preferred
Personal skills
Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization. Required
Manage multiple priorities and work with interruptions. Required
Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required. Required

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