QA Engineer

Job Description:

• Plan and manage product quality, including product qualification and design validation.
• Create and maintain documentation such as Acceptance Test Plan (ATP), Acceptance Test Record (ATR), Inspection Plan (IP), SOP, Work Instruction, Test Procedures and Calibration Procedures.
• Participate and contribute in New Product Introduction Process and understand specification development and verification upon transition to production.
• Participate and contribute in process or production yield improvement projects by applying statistical tools and Six Sigma methodology.
• Participate in Material Review Board (MRB) and disposition of nonconforming materials (internal).
• Review product concession and deviation notices for adequacy and correctness prior to submission for customer approval.
• Manage Customer Returns (Return Materials Authorization (RMA)) and coordinate with cross functional team to process and close with root cause analysis and corrective actions and report monthly status.
• Analyze and report on Customer Quality Performance.
• Coordinate the site's Corrective and Preventative action process relevant to customer complaints including root cause analysis, verification of effectiveness and closure of corrective and preventative action.
• Assist in training and maintenance of the site Quality Management System: AS9100, ISO9001 and any other applicable standards such as ISO13485 for Medical Devices.
• Support and participate in Certification Body and customer audit and conduct internal and supplier audits.
• Support and participate in upgrading and enhancing measurement system capability.
• Lead and/or support groups of technicians or engineers in quality activities
• Perform ad hoc tasks as required.
• Keep up to date with developments and trends in Quality Best Practices and Regulatory Standards.
• Communicate and work with suppliers to address material quality and documentation issues as reported by Incoming QA and Production departments.
• Facilitate and/or participate in Material Review Board (MRB) meeting for disposition of nonconforming materials, and/or meeting with relevant internal departments (R&D, Engineering, Sourcing, QA, Sales, Production, etc.) to address manufacturing issues or disputes relevant to supplier materials/documentations and ESG drawing specifications/requirements.
• Review and approve supplier records/reports including but not limited to: First Article Inspection Report, Specification Review Form (SRF), SCAR, Control Plan, GRR and Cpk Reports, etc., where applicable.
• Participate in Supplier Readiness Checklist and/or FAT meeting to support Sourcing and Purchasing department in communicating/flow-down ESG and Customer Specific Requirements to suppliers.
• Issue Supplier Containment Action Notice (SCAN) and Supplier Corrective Action Report (SCAR) to supplier and follow-up on supplier reply for review and closure.
• Provide guidance to supplier to meet ESG and Customer Specific Requirements.
• Support Incoming QA department in conduction measurement correlation with relevant internal departments and suppliers.

Job Requirements:

• Bachelor’s degree in Optics, Electrical, or Mechanical Engineering preferred; alternatively, an Associate Degree or Diploma with at least five years of experience in a manufacturing environment will also be considered.
• Minimum of five years’ experience in a manufacturing environment, with experience in the optics industry being a strong advantage.
• Solid background in life sciences, medical, semiconductor, optronics, or avionics manufacturing environments is a strong plus.
• Experience in customer and supplier quality management is desirable.
• Experience in NPI (New Product Introduction) process management and product quality planning.
• Experience in ISO cleanroom or similar GMP environments.
• Experience in change control and management processes.
• Hands-on experience as a certified auditor in ISO 9001 and/or AS9100 QMS will be highly desirable.