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.

Skills

Medical, manufacturing environment, Avionics Equipments, Npi, GMP Environment, Electrical, AS9100, experience in optical, Supplier Quality Management, Semiconductors, Process Quality Management, Optics, Electrical Engineering (including power engineerin, New Product Introduction, Change Management Process, Life Sciences