Quality Engineer II

Job Responsibilities

• Investigate moderately complex manufacturing product quality and compliance issues which may include:
• Investigate PRAs and complaints for manufacturing related issues
• Manage site NCRs, CAPAs, ECRs and audit observations for all production processes before final product release based on engineering principles; analyze results,
• Provide technical support to external and internal audits,
• Make recommendations and develop reports.
• Oversee product release, assess and disposition product on hold (MRB), and manage material quality control.
• Review and approve equipment validations and asset management actions.
• Collaborate with engineering teams to ensure successful transfers.
• Develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team where applicable for the plant site.
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
• Support the following:
• Process validation or support/lead TMV
• Sustaining Quality Engineering responsibilities such as reviewing Quality Metrics, Material Review Boards, Quality Control, etc.

Qualifications

• Bachelor's degree in engineering required.
• 2-4 years' experience required.