Quality Technician

Masimo; Pasir Gudang; On-site; MYR 36,000 - 52,000; Full time

Job summary

A global medical technology company in Pasir Gudang is seeking a Quality Technician to ensure product quality throughout the manufacturing process. The successful candidate will have at least 3 years of experience in product quality, good communication skills, and proficiency in Microsoft Office. The role involves multiple responsibilities, including quality inspections and compliance with quality standards. This position requires both lab and office work in a dynamic environment.

Qualifications

• Minimum 3 years of experience in Product Quality required.
• Independent worker with adaptability and flexibility needed.
• Direct experience in quality laboratory system is essential.

Responsibilities

• Assist in development and implementation of quality documents.
• Ensure appropriate use of documentation during manufacturing.
• Control non-conformance material and ensure calibration.

Skills

Product Quality

Communication Skills

Assembly & SMT line experience

Microsoft Office proficiency

Education

Professional Certificate / Diploma in Science or Engineering

Job description

Job Summary:

Quality Technician responsible for providing technical support for all aspects of quality engineering throughout the product realization process and Quality System. This position will handle multiple projects from product validation, through manufacture and Quality System Requirements. The incumbent provides a key role to ensure product meets defined quality standards and Quality System Requirements are met. The incumbent will also support all facility activities, including process validations, new product introduction, and inspection and test activities or others related to the Quality from time to time

Duties & Responsibilities:

• Assist in development and implementation of documents applicable to the Quality validation & inspection
• Ensure, through training and verification, the appropriate use of current documentation, as well as the use of good documentation practices during all the stages of manufacturing.
• Ensure and monitor the applicable documents for Quality inspection are available in the point of use, this includes, but is not limited to the visual aids with physical samples.
• Coordinate Inspection activities and product release for further processing, for incoming and outgoing in all areas.
• Ensure to follow the updated procedure.
• Ensure that acceptance criteria are met and updated.
• Ensure that product status is clear during all the stages of the manufacturing process.
• Support in New Product development and validation, generating Acceptance Procedures and Quality Documents (new documentation)
• Control of Non-Conformance Material.
• Ensure that all Inspection Equipment that requires calibration, is calibrated.
• Ensure to follow DHRs and close on time per applicable procedures.
• Follow-up in the MRB process and actions to reduce non conformances.
• Assist in Quality System activities such as: follow PDA process, Internal Audits, Internal Observations, Document Control and providing data for reports.
• Assist in quality assurance and product quality
• Supports new product development and product manufacturing through the application of quality engineering tools
• Any reasonable task assigned by Superior from time to time

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• Minimum experience of 3 years in Product Quality.
• Good English communication skills, written and oral.
• Experience in Assembly & SMT line
• Ability to interact with different departments
• Direct experience in quality laboratory system, calibration, testing and audits
• Proficiency with Microsoft Office applications
• Must be independent worker, who is flexible and adaptable

Preferred Qualifications:

• Microsoft office knowledge
• Experience in Risk Management to ISO 14971 and IEC 60601-1, 3rd Edition
• Experience in testing products to follow Product quality Standards
• Certified as an ISO internal auditor should be advantageous

Education:

Professional Certificate / Diploma in Science or Engineering is required and or another related equivalent

Physical requirements/Work Environment

This position works in office, laboratory and manufacturing environments. It requires frequent sitting, standing, and walking. He or she needs to be able to recognize and differentiate color. He or she must also be able to lift up to 50 pounds. Daily use of computer and other computing and digital devices is required. He or she may stand for extended periods when facilitating meetings, walking in the facilities, performing audits and laboratory testing. The ability to operate a motor vehicle and maintain a valid driver 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 reals or perceived disabilities to perform the essential functions of the job described