Quality Control Operator

Location : Batu Kawan, Penang Malaysia
Salary Range : RM1800 - RM 2000

About our client :
This company is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue.

Job Highlight :

• Development opportunities working with industry experts.
• Opportunity to use world class systems and technologies.
• Work and life balance.

Responsibilities

100% responsible for the below:

• Conduct visual and dimensional inspections of raw materials, components, and manufactured products to ensure compliance with specifications.
• Conduct testing and sampling according to established procedures.
• Identify and report non-conforming materials to Senior Quality Control Technician.
• Monitor and enforce compliance with quality standards and specifications.
• Comply to HSE policy, Sustainability and Energy Policy, HSE regulations and HSE rules.
• Prevent safety and health injuries, environmental pollutions, and energy wastage.
• Report all HSE incidents & provide feedback for HSE improvements

Quality Assurance:

• Adhering to quality assurance procedures and standards.
• Ensure compliance with regulatory requirements such as FDA regulations, ISO 13485 standards, and other applicable guidelines.
• Collaborate with Senior Quality Control Technician and managers to identify areas for improvement in quality, efficiency, and reliability.

Documentation and Reporting:

• Maintain inspection records.
• Communicate inspection findings and quality-related concerns to Senior Quality Control Technician.
• Support investigations, audits, and other quality-related activities.

Process Improvement:

• Participate in continuous improvement initiatives to enhance overall quality processes.
• Monitor production and quality control procedures to identify inefficiencies and recommend solutions.
• Work with cross-functional teams to develop corrective and preventive actions.

Training and Development:

• Participate in training and guidance on quality standards, procedures, and best practices.

Licenses/ Certifications/ Competencies/ Experience

• Knowledge of ISO 13485, ASME Y14.5, and ASTM standards preferred.
• Minimum 2 years of experience in a quality control role within a machining environment preferred.
• Experience using quality tools such as 5 Why, Ishikawa, and GD&T interpretation is an advantage
• Hands-on experience with metrology equipment, including CMM (Zeiss CONTURA preferred), Keyence Optical Inspection, and non-contact surface roughness inspection.

Education: SPM or Technical Education with advanced training in Metrology Engineering preferred.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The Quality Control Operator will spend approximately one-third of this time walking or standing.
• The Quality Control Operator may spend less than 10% of his time at a computer keyboard. He must also be able to take measurements using hand instruments and electronic laboratory equipment. 
• The Quality Control Operator must be able to speak and hear well enough to communicate effectively. Since he must visually inspect products, vision must be excellent or corrected.

Additional Requirements:

• Willingness to work on shift rotation, including night shifts, as well as overtime as needed to support production schedules.
• Experience with SAP Quality Module interface (Quality result recording, Usage decision, Quality notification, etc.).
• Ability to collaborate effectively across departments to support production and quality objectives.