Manager, Quality

Job Summary:

The Quality Manager is responsible for establishment and implementation of the quality system to support processes and activities at the Malaysia facility. The quality system supports production of products consistent with established specifications and standards. Develops, implements and analyzes statistical controls and data gathering to monitor processes and confirm the quality of finished product. This position develops and maintains key quality control indicators and coordinates with operations to ensure ongoing product quality. The Quality Manager directs activities for the inspection and testing of products to ensure control through the entire product realization process. The Quality Manager also plans, promotes, and organizes activities related to product quality and reliability training. 

Duties & Responsibilities:

• Ensure the Company’s quality system is effectively implemented and supported in the Malaysia facility.
• Implement and maintain effective statistical process controls and other statistical techniques to ensure manufacturing output is in control and monitored.
• Responsible for the coordination of Incoming, In-Process, and/or Finished Goods Acceptance Testing;
• Responsible for coordinating revisions to Acceptance Procedures with Masimo Corporate;
• Ensures that required inspection equipment is available, maintained, and calibrated;
• Initiates actions required to prevent and/or eliminate the occurrence or recurrence of all nonconformities relating to the product, process, and/or quality system.
• Verify the effective implementation of resolutions to quality problems.
• Responsible for the establishment and management of quality metrics generated for the Malaysia facility.
• Management of the nonconformance control process in the Malaysia facility.
• Manage the implementation of quality improvement projects including process improvements and ensure timely implementation.
• Direct, plan, delegate and manage department budget and staff including: 
  • Hire, promote,  or terminate employees 
  • Write and conduct performance appraisals and disciplinary actions 
  • Make salary decisions (pay increases or new hire offers) 
  • Create training and employee development plans 
• Handle all departmental employee relations issues

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• Minimum of 5 years managerial experience of Quality Assurance and Quality Control activities.
• Experienced in Quality System Regulation, ISO-13485:2016 and MDA requirements for Malaysia.
• Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering, manufacturing, sales, marketing, administration, customers and other third parties.
• Good conceptual, analytical, problem solving, and organizational skills.
• A “hands-on” individual, who enjoys challenges, is capable and dedicated to getting the job done with minimal support and direction.
• A mature thinking and acting manager with good common sense and judgment, and a broad business perspective with outstanding administrative capabilities to build, motivate and manage a strong quality organization.
• Well-organized and accustomed to maintaining excellent records;

Preferred Qualifications:

• Not applicable

Education:

Bachelor’s degree, preferably in a technical discipline

Physical requirements/Work Environment

This position primarily works in an office and manufacturing/production environment. It requires frequent sitting, standing and walking.  Daily use of a computer and other computing and digital devices is required.  May stand for extended periods when facilitating meetings or walking in the facilities.  Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required. 

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods.  Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described