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.