Senior QA Engineer

Dexcom; Seberang Perai; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading medical device company is seeking a Senior Quality Engineer to oversee compliance with safety, quality, and regulatory standards. You will design inspection methods, manage quality assurance protocols, and support internal audits. Ideal candidates will have a Bachelor's degree and 5+ years of experience in the industry. Strong communication skills and proficiency in Microsoft Office are essential. This is a critical role for ensuring product quality and process improvement.

Qualifications

• Minimum 5-8 years of related experience, or 2-5 years with a Master's.
• Medical Device experience preferred.
• Knowledge of FDA 21 CFR 820 and ISO 13485.

Responsibilities

• Plan, implement, and manage compliance of manufacturing processes.
• Design methods for inspecting and testing products.
• Perform internal audits to ensure compliance.

Skills

Strong communication skills

Presentation skills

Interpersonal skills

Analytical skills

Education

Bachelor's degree in relevant field

Master's degree in relevant field

Tools

Microsoft Office

Excel

Power BI

MiniTab/JMP

Job description

We are seeking a Senior Quality Engineer who able to work in fast-paced environment. Possesses advanced knowledge of technical principles and theories, applies company policies and procedures to resolve a variety of issues. Works on problems of more complex scope where analysis of situations or data requires a review of a variety of factors. Exercises good judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.

Essential Duties and Responsibilities

Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution.

Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.

Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.

May assure compliance to in house and/or external specifications and standards (i.e. GLP, GMP, ISO Six Sigma).

Involve in review, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.

Involve in designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.

May supervise and administer specific aspects of the quality system.

Develops systems and performs quality functions that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training.

Performs internal audits to ensure systems consistently comply with requirements and are effective.

Participates as member of the design team. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.

Leads risk management, validation, sample size, and external standards review and implementation activities.

Employs techniques like six sigma, lean manufacturing and Total Quality Management to improve Dexcom operations.

Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.

Coordinates the disposition of nonconforming materials with the Materials Review Board.

Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.

Reviews schematics and mechanical drawings.

Assumes and performs other duties as assigned.

Required Qualifications

Bachelor’s degree and minimum of 5-8 years of related experience; or Master’s degree and 2-5 years equivalent industry experience.

Medical Device experience preferred. Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems).

Must have strong communication, presentation, organization, planning, and the interpersonal skills necessary to work as a team member and act as a liaison with customers.

Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel, Power BI, MiniTab/JMP) is preferable.