Job Description

Job Title: Senior Quality Engineer

Job Location: Sturtevant, WI

Job Type: 5+ Months contract

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
• Identifies new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies
• Works 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

Adherence to regulations:

• 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 of Science (B.S.) Physical Science or Engineering
• 3-5 years Quality Engineering role
• 6-7 years Medical Device or Pharmaceutical Industry
• ASQ Certification as a Quality Engineer preferred
• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations

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