The Quality Engineer II will be responsible for the execution and tracking of daily production support activities regarding all aspects of product quality as well as provide support on site projects.

Major activities include, but are not limited to:

• Perform risk assessments for nonconformances, CAPAs, ECOs. Etc.
• Act as in internal consultant to various departments and teams for current interpretation of GMP/ISO/QMS.
• Review equipment validations to support ad-hoc limited qualifications, new equipment qualifications, equipment and facility requiring re-qualifications, calibrations, etc. Ensure appropriate qualifications activities are performed and documented in compliance with GMPs, GTPs, and GDPs.  Review and approve validation documents in BRAM system, including remote off-shift review as required.
• Review and approve documents under Change Control ensuring compliance with GMP, GDP, GTP, and regulatory standards such as ISO13485, 21CFR820, ISO14971, etc.
• Support the Risk Management process throughout all quality system elements such as Design Control, Product Surveillance, Field Action, etc.  Update risk management file documents as needed.

• Provide Quality support on project work and lead projects related to core production while ensuring compliance with applicable regulations/standards. Challenge the approach and provide innovative alternative solutions to protocol designs.
• Provide guidance and direction on NCR and CAPA investigations.  Complete NCRs, CAPAs, and ECOs as required
• Recommend enhancements / continuous improvements to the Quality Management System and QMS procedures.

Education and Experience

• Bachelor’s degree required in Engineering or Science
• Minimum 3 years of Quality Assurance/Quality Engineering/Engineering/Operations experience
• Validation lifecycle experience helpful but not required
• Risk Management experience preferred
• CAPA lifecycle experience, including root cause investigation
• 21CFR820 and 1271
• Technical writing
• Basic statistics
• Presentation and communication skills
• GMP, GDP, GTP understanding
• Change Control experience
• Audit support experience helpful, but not required