Quality Engineer II

Key Responsibilities

• Provide Quality Engineering support for engineering project development, or sustained manufacturing.
• Provide Quality Project Management support as needed for product transfers from development to validation.
• Develop and maintain Validation Standard Operating Procedures.
• Develop and maintain project Quality Plan for assigned projects.
• Develop protocols, perform statistical analyses, and write reports for validations and formal process development, which requires quality-engineering involvement such as DOEs.
• Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
• Conduct validations to ensure robust processing and monitors output to reduce PPM failures.
• Support Risk Management activities for New Product Development (NPD) programs within our Precision Component Business.
• Provide Quality Engineering support for manufacturing.
• CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.
• Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing.
• Provide Quality Support for the disposition of material via NCR’s.
• Provide Quality Project Management Support as needed for product transfers from validation to production.
• Vendor approval and maintain and assess vendor performance data (i.e. SCAR/on time).
• Review and document procedure changes for quality requirements and compliance with the quality system.
• Develop quality systems and procedures as needed.
• Audit support for third party audits, customer audits and internal audits.
• Support the implementation of continuous improvement initiatives for production processes.
• Develop and maintain production quality control plans.
• Initiate and maintain SPC (Statistical Process Control) for production processes.
• Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable).

Qualifications

• A Bachelor’s degree in a STEM engineering discipline.
• 2+ years of experience in Quality Engineering required.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).