Quality Control Supervisor

Masimo; Pasir Gudang; On-site; MYR 80,000 - 100,000; Full time

Job summary

A leading medical device manufacturer in Johor, Malaysia is seeking a Quality Control Supervisor to lead quality assurance initiatives and ensure adherence to industry standards. The ideal candidate has over five years of experience in quality control within regulated environments and possesses strong communication skills. This role involves supervising QC technicians, managing acceptance testing, and reporting on quality metrics.

Qualifications

• Five or more years of experience with quality control inspection and testing.
• Experience working within a Quality Management System in a regulated industry.
• Ability to travel domestically and internationally, up to 10% of the time.

Responsibilities

• Supervises the daily activities of Quality Control/Assurance Technicians.
• Coordinates Incoming, In-Process, and Finished Goods Testing.
• Prepares and reports QC metrics at QMS reviews.

Skills

Quality control inspection and testing

Good communication skills

Interpersonal skills

Computer Skills in Microsoft Office

Education

Associate’s degree in industrial or technical field

Tools

Agile PLM

Job description

Job Summary

The Quality Control Supervisor ensures the maintenance and effective implementation of Masimo’s quality system at the Malaysia facility.

In the Quality Control Supervisor role, the incumbent is responsible for assisting with the planning, coordinating, and directing the quality program to ensure continuous distribution of products consistent with established standards. Monitors and analyzes statistical data and product specifications to determine conformance of incoming raw materials, subassemblies, and finished products in accordance with established company requirements and specifications, and applicable industry standards. The incumbent directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products. The Quality Control Supervisor will stay abreast of new, changed, and emerging standards related to Quality Control and advise appropriate managers and departments of changes that could affect Masimo activities.

Duties & Responsibilities

• Supervises the daily activities of the Quality Control/Assurance Technicians and Inspectors;
• Ensures training and up to date training records for the Quality Control/Assurance Technicians and Inspectors;
• Coordinates Incoming, In-Process, and/or Finished Goods Acceptance Testing for parts/ products;
• Reviews, accepts and maintains documentation of Acceptance Testing;
• Performs modifications of Acceptance Procedures, as required;
• Ensures timely inspection of acceptance activities, including prioritization;
• Organization and management of the Quality Control Records;
• Ensures Quality Control/Assurance personnel are trained to the latest procedures;
• Ensures that adequate inspection equipment is available, maintained, and calibrated;
• Prepares and reports QC metrics at QMS reviews;
• Performs other duties or special projects as requested;
• Executes identification, segregation, creation and management of non-conforming products and processes.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications:

• Five or more years of experience with quality control inspection and testing of electronic components, subassemblies, and finished products;
• Knowledge and experience working within a Quality Management System (QMS) in a regulated industry;
• Good communication skills, verbal and written;
• Ability to travel domestically and internationally, as needed, up to 10% of the time;
• Good interpersonal skills dealing with peers and other functional areas;
• Computer Skills in Microsoft Office suite.

Preferred Qualifications:

• Prior experience in a Medical Device manufacturing environment;
• Experience with Agile PLM is preferred;
• Familiar with Part 820 Quality Systems Regulation;
• Familiar with ISO-13485 requirements;
• Prior Experience in managing large group of people (50 to 75)
• Able to work in shift / 6 days

Education

Associate’s degree, preferably in an industrial or technical field is required. Bachelor’s degree in engineering, manufacturing, industrial design, or related field is preferred

Physical requirements / Work Environment

This position primarily works in an office, laboratory, and manufacturing environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital/mechanical devices is required. May sit or stand for extended periods. Must be able to regularly lift up to 35 pounds. Local, domestic, and international travel up to 10% of the time may be necessary.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.