QA Engineering Technician

Dexcom; Seberang Perai; On-site; MYR 45,000 - 60,000; Full time

Job summary

A leading medical device manufacturer is seeking a quality technician to ensure the compliance and quality of manufacturing processes. Key responsibilities include supporting quality engineering, conducting inspections, and collaborating with various teams to maintain high standards. Candidates should have a diploma and 4-6 years of relevant experience, preferably in medical devices, along with strong skills in quality control and detail orientation. This role offers growth opportunities and a comprehensive benefits program.

Benefits

Comprehensive benefits program

Growth opportunities

Career development programs

Qualifications

• Minimum 4-6 years of quality control experience in a manufacturing environment.
• Knowledge of FDA 21 CFR 820 and ISO 13485 is an advantage.
• Ability to work independently with minimal supervision.

Responsibilities

• Support quality engineering activities including nonconformance handling.
• Conduct inspections throughout the manufacturing process.
• Collaborate with cross-functional teams for quality assurance.

Skills

Quality control

Attention to detail

Problem-solving

Data collection and inspection

Computer skills (Microsoft Office)

Education

Diploma or equivalent

Job description

Overview

We are seeking a quality technician who able to work in fast-paced environment. Perform functions associated with quality control and quality assurance operations and play a crucial role in ensuring the quality and compliance of our manufacturing processes is well maintained. This position involves nonconformance event processing and analysis, internal/ external audit support, quality documentation review and processing, and collaborating with cross functional team to maintain product quality and integrity. May assist in developing methods and procedures for quality assurance and control.

Responsibilities

• You support quality engineering activities such as change order processing, nonconformance event handling (e.g., NCMR, out of tolerance, excursion), and execution or verification of validation protocols.
• You collect data and conduct inspections throughout the manufacturing process, from receiving inspection to product release, to support investigations led by Quality Engineers.
• You support production by maintaining a strong presence on the manufacturing line and assisting the inspection team with questions related to methods or processes.
• You may support Quality Engineering in ensuring compliance with in-house and/or external specifications and standards (e.g., GLP, GMP, ISO, Six Sigma).
• You update and maintain quality assurance protocols and methods for processing materials into partially finished or finished products.
• You ensure compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards for worldwide distribution.
• You support and work on nonconformance reports, collaborating with cross-functional teams in event assessment, QA verification, and material disposition.
• You perform regular line audits to ensure systems comply with requirements and remain effective.
• You provide assistance and support to Quality Engineering and Operations in resolving day-to-day production quality issues and implementing corrective actions.
• You identify opportunities for process and quality improvement and contribute to continuous improvement initiatives to enhance product quality and process efficiency.
• You communicate any concerns about work processes regarding environmental impact, health, or safety issues to your manager.
• You read and understand specifications and inspection criteria, applying them using appropriate and properly configured inspection tools.
• You review and interpret engineering drawings and specifications.
• You demonstrate decision-making ability and work independently with minimal supervision.
• You may assist in training and mentoring junior technicians.
• You apply intermediate computer skills in the use of Microsoft Office.
• You maintain excellent attention to detail.
• You assume and perform other duties as assigned.

Qualifications

• You must possess at least Diploma or equivalent and minimum 4-6 years of related experience. Proven experience in quality control or related role within manufacturing environment are preferred.
• You have medical device experience preferred. Some knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems) will be added advantage.
• You adopt hands on approach and able to perform shift duties.
• Your proficiency in Microsoft office application knowledge.

What you’ll get

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
• Travel Required: (Highlight the appropriate range)

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