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 Change Control, NCR/CAPA, Product Surveillance, Design Control, New Product Development, New Markets and Risk Management. 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

Change Control

• Product SME supporting Change Control Activities (Engineering, Design, etc.). Originate, review, and approve operating procedures and specifications through the Change Control process.

NCR and CAPA

• 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.

Design Control

• Be the lead quality team member on Design Control Projects supporting the development and validation of new products.

Product Surveillance

• 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.

New Markets

• 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)

Risk Management

• 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.

Internal and Vendor Audit

• Supports Internal and Vendor Audit Functions as needed

Process improvement initiatives

• Coordinates process improvement initiatives

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

Education

• BS in a Physical Science or Engineering, or equivalent experience required.
• ASQ Certification as a Quality Engineer or equivalent. Preferred
• BS Engineering Preferred

Professional experience

• 6 years' work experience Required
• at least 4 years in Quality in Medical Device or Pharmaceutical industry 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
• 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