Quality Assurance Manager

JOB SUMMARY:

The Quality Assurance Manager leads the Quality Management System, leads quality improvement efforts based on customer feedback, manages supplier quality, supports new product introductions, manufacturing, and continuous improvement initiatives. This role collaborates with cross-functional and global teams to drive operational excellence and supports the OKI Shenzhen, China operation and product lines

JOB DUTIES

• In charge of managing the Quality Management System with the goal of achieving its targets as specified in the established quality policy & objectives. 
• Ensure Quality Management System compliance to applicable standards. 
• Propose and Implement process changes to improve efficiency, productivity and overall effectiveness of Products 
• Plan short-range and long-range action-steps to carry out goals to meet targets.
• Assign/delegate jobs to subordinates.
• Train Q.E. subordinates.
• Conduct performance evaluations of subordinates.
• Leads internal audits and 3rd party audits for the Quality Management System. 
• Oversee Technical Service Manager. 
• Develop and initiate standards and methods for inspection, testing, and evaluation utilizing knowledge in engineering fields such as electrical and mechanical.
• Determine critical dimensions and devise control plans, sampling plan and procedures.
• Design and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Evaluate and participate in design of products according to specifications and quality standards in accordance with the Product Development Process (PDP).
• Evaluate existing and potential supplier systems and processes.
• Drive the Quality department to meeting established goals for warranty, scrap, and FPY.
• Participate in the Design Control Process, review design inputs (specifications) and design outputs (reports, prints, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer.
• Review, approve and develop (as needed) product verification plans, validations and respective test methods through the development of a protocol and Final Reports.
• Participate in Engineering Change Notification (ECN) process to review and approve engineering change requests.
•  Manage Material Review Board (MRB) to review and disposition nonconformities and to work with Supplier Quality Engineering to coordinate supplier corrective actions.
• Work with Manufacturing to coordinate, and monitor production processes to ensure compliance to applicable regulatory requirements, to ensure that safe and effective products are produced and to identify continuous improvement opportunities.
• Support manufacturing readiness for new product launch buy designing assembly process & required custom tooling. 
• Ensure that assembly cycle times meet required goals.  
• Provide validation qualification support by applying manufacturing quality tools including, but not limited to: FMEA, control plans, process verification/validation plans, protocol and final report development, Cpk, SPC, DOE and process data analysis.
• Ensure that all documentation is provided to establish compliant product and process qualifications.
• Monitor performance aspects by gathering relevant data and producing statistical reports.
• Participate in complaint investigations, failure analysis of returned products, and issues resulting in a stop ship/stop production; document findings, provide reports and analysis, & document health risk assessment.
• Liaise with Customer Support group and ensure the execution of Compliance actions in support of regulatory requirements.
• Routine management and execution of the Custom Product process.
• Performs other duties as assigned.

WORK EXPERIENCE REQUIREMENTS

• 8+ years of quality assurance management experience directly related experience in electro-mechanical assembly and component design. Strong manufacturing and Lean Principle background. Effective verbal and written communication skills.

SKILLS REQUIRED

• Bilingual, English & Mandarin highly desirable
• Must have strong problem solving and time management skills.
• Results-oriented work ethic.
• High energy and the ability to multi-task across projects.
• Must be able to understand the product as a system as it encompasses mechanical, electrical, and software integration.
• Must be familiar with general Quality Assurance practices and procedures.
• Able to Read, analyze, and interpret technical procedures and governmental regulations.
• Write technical reports, business correspondence, technical procedures, as well as, administrative procedures.
• Must be able to determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives.
• Must be familiar with sampling plans and techniques. 
• Inspection plan creation.
• Proficient using SolidWorks software
• Knowledge of drawing and schematic interpretation, product models, geometric dimensioning and tolerance establishment.
• Knowledge of injection molding process.
• PCBA, wire harness, electro-mechanical, machining, casting and sheet metal fabrication, assembly and inspection process knowledge.
• Lead the Quality Assurance team which includes the Technical Service team & Technical Services Manager. 
• Experienced in use of statistical tools and techniques for quality management.
• ISO 9001-2015 Quality Management System.
• Office tools and equipment including Microsoft Office and ERP systems.
• Strong written and oral communications skills with ability to interface with all levels.
• Ability to work cooperatively and productively with other employees and suppliers.