Quality Engineer II

What You'll Do:

The Quality Engineer II will support the development and manufacturing of Class III medical devices. This individual will work with Medical Safety, Product Development and Manufacturing to resolve product quality issues. The Quality Engineer II will also support manufacturing process changes, product design improvements and the implementation of new products.

• Primary responsibilities include working in Quality Engineering and with other functional groups in support of product nonconformity investigation.
• Review process changes and resolve product quality issues.
• Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
• Lead and perform complaint evaluation as appropriate.
• Train, coach, and guide lower-level employees on routine procedures.
• Develop trend requirements to support the QA/QC department in the following areas: NCR, CAPA, and SPC processes for incoming inspection, process, and vendor operations. Evaluates data and identifies trends in order to develop innovative solutions.
• Develop and establish effective quality control
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, document change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process
• Provides technical assistance/oversight in defining and conducting both internal and external product and process validations and requirements, working closely with Product Development, Applied Research, and Manufacturing personnel as well as vendors. Writes, performs, and/or reviews technical documents such as Validation Protocols, Test Procedures, and Test Reports.
• Responsible for conducting, documenting, and maintaining risk analyses for all development products and complying with risk analysis, design control, and any other related procedures.
• Manage equipment and facility (including clean room) requirements, design, maintenance, calibration and validation programs.
• Ensure compliance with all Federal, State, local and company regulations, policies, and procedures.
• Performs other quality-related duties as assigned by management.
• Assists with creation of new efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.

How You'll Get There:

• Bachelor's degree in Engineering or Science
• 2-5 years of relevant work experience
• Strong knowledge of medical device manufacturing
• Expertise in medical product quality assurance (including the requirements for test protocols and statistical techniques)
• Working understanding of GMP and ISO 13845 requirements
• A work style of hands-on involvement with all phases of projects
• Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirable
• Excellent documentation skills with attention to detail and accuracy Required
• Team player, good written/oral communicator

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