Supervisor, Manufacturing

Masimo Corporation; Pasir Gudang; On-site; MYR 50,000 - 70,000; Full time

Job summary

Masimo Corporation is seeking a Manufacturing Supervisor in Pasir Gudang, Malaysia. This role involves supervising the day-to-day operations of manufacturing personnel, ensuring compliance with quality and regulatory standards while achieving production goals.

The ideal candidate should have at least 2 years of supervisory experience, a Bachelor's degree in Industrial Engineering, and knowledge of ISO 13485 standards. The job also requires effective communication with various teams and adherence to good manufacturing practices.

Qualifications

• Minimum 2 years of supervising experience.
• Ability to communicate effectively with co-workers and management.
• Knowledge of ISO 13485 and CGMP requirements.

Responsibilities

• Supervise manufacturing personnel to meet production goals.
• Ensure compliance with regulatory and quality standards.
• Document assembly steps and acceptance criteria.
• Monitor and manage production line efficiency.
• Conduct investigations for product rejection causes.

Skills

Communication Skills

Supervisory Experience

ISO 13485 Knowledge

CGMP Requirements Knowledge

Knowledge of FDA and ISO Medical Device Requirements

Experience with Electrical/Optical Products

Education

Bachelor’s degree in Industrial Engineering

Job description

The Manufacturing Supervisor is responsible for the day-to-day supervision of all manufacturing personnel within their department. This position ensures build plans are achieved with the highest level of customer satisfaction and quality, while also ensuring compliance to all regulatory and quality regulations.

Duties & Responsibilities

• Comply with the procedures defined in the Quality System, Company Policies and Malaysian Labor Law.
• Supervise hiring, training and performance of associates and leads.
• Work together with Quality and Process engineering department to clearly document steps and acceptance criteria of the product assembly in the appropriate manufacturing documentation (MAP and AP’s) and Visual aids.
• Ensure and monitor that the manufacturing lines have available appropriate manufacturing documentation to assembly products such as visual Aids, Physical Visual aids y manufacturing documentation.
• Ensure manufacturing lines have printed and posted in each process workbench visual aids and physical visual aids as required for easily access of the document in a manner that the associate and leads can have product acceptance criteria as reference
• Ensure adherence to procedures and to good manufacturing practices.
• Meet production schedule within Efficiency and yield goals. Achieve company’s metrics.
• Ensure Line Balancing document is available in production line and work with leads, process engineer and industrial engineer to assign workloads to each assigned work station with personnel available in order to improve efficiency, reduce/eliminate bottlenecks, minimize associates downtimes and eliminate waiting waste.
• Perform Disciplinary sanctions according to internal regulations.
• Supervise proper material identification and segregation (Raw material and Finished Product).
• Elaboration of reports requested by Management.
• Support the company activities and projects
• Report unsafe conditions or actions.
• Ensure a clean and orderly workplace.
• Make sure that all the personnel wear their personal safety equipment.
• Comply with personnel rotation and ergonomic requirements.
• Perform investigations to identify non-conformant product rejection causes and actions to prevent the recurrence

Minimum & Preferred Qualifications and Experience

Minimum Qualifications:

• Supervising experience (2 years).
• Have the ability to communicate written and oral and establish professional and effective interaction with co-workers, subordinates, Engineering and Quality Assurance

Preferred Qualifications:

• Have knowledge/experience on ISO 13485 requirements and the Quality System Regulation
• Knowledge and experience in CGMP requirements and preferably FDA and ISO medical device requirements;
• Experience with electrical/optical products

Education

Bachelor’s degree in Industrial Engineering or equivalent in experience

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