Staff QA Engineer

Dexcom Deutschland GmbH; Simpang Ampat; On-site; MYR 284,000 - 367,000; Full time

Job summary

A leading medical technology company located in Penang, Malaysia, is seeking a Staff QA Engineer. The successful candidate will be responsible for designing and implementing quality assurance protocols, managing compliance with safety and quality standards, and conducting audits. A Bachelor's degree with significant experience in medical devices is required, alongside strong communication and statistical tool proficiency. This role is crucial for maintaining the integrity of quality management systems within the organization.

Qualifications

• Bachelor’s or Master’s degree with relevant experience in the medical device industry.
• Strong understanding of FDA and ISO quality management systems.
• Proven experience in root cause analysis and corrective actions.

Responsibilities

• Design and implement quality assurance protocols for production processes.
• Conduct audits to ensure compliance with quality standards.
• Analyze production data to recommend quality improvements.

Skills

Strong communication skills

Statistical tools proficiency

Quality methodologies knowledge

Teamwork and liaison abilities

Education

Bachelor’s degree in relevant field

Master’s degree

PhD in relevant field

Tools

Microsoft Excel

MiniTab

Power BI

Job description

Staff QA Engineer

Penang, Malaysia

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we’re just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we’ve started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We’ve already changed millions of lives and we’re ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We’ll get there by constantly reinventing unique biosensing‑technology experiences. Though we’ve come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Summary

Position may be responsible for various aspects of Quality Engineering, including supervision of support personnel and/or administration of specific aspects of the quality system. A senior technical leader responsible for driving advanced quality engineering strategies, leading complex problem‑solving efforts, influencing cross‑functional teams, and ensuring robust product and process quality throughout the product lifecycle. Job tasks require interfacing with all functions (Operations, Quality Assurance, Engineering, Regulatory Affairs, Clinical Affairs, Biometrics, Marketing, Legal, Finance, Sales, Customer Operations, Human Resources and upper levels of management). Personnel in this role must be systematic, highly organized and articulate and work in a team environment. A positive attitude is important while working in a fast‑paced environment and dealing with shifting priorities.

Essential Duties And Responsibilities

• Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.
• 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.
• Takes the initiative to develop systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
• 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.
• Responsible for reviewing, authoring, and revising appropriate technical documentation including design history file, standard operating procedures, protocols, reports, etc.
• Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Equipment, Process, Software and Test Method Validation, Auditing, Calibration, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training.
• Leads or participates in internal audits, supplier audits to ensure systems 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.
• Designs and performs Equipment, Process, Software and Test Method Validations.
• Provides technical guidance with respect to equipment, software, product, and process requirements including defining and identifying failure mode effects and analysis (FMEA).
• Applies risk management, validation, sample size, and external standards review and implementation activities.
• Assists with investigation and disposition of nonconforming materials with the Materials Review Board.
• Able to review schematics and mechanical drawings; this include read, write, and understand specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
• Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and MiniTab).
• May assure compliance to in house and/or external specifications and standards (i.e. GLP, GMP, ISO Six Sigma).
• May supervise and administer specific aspects of the quality system.
• Assumes and performs other duties as assigned.

Required Qualifications

• Bachelor’s degree and minimum of 8 years of related experience; or Master’s degree with 5 years equivalent industry experience; or a PhD with 2 years of related experience; or equivalent combination of education and 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.
• Proficiency with statistical tools (Minitab, JMP, or equivalent) and hands‑on experience in root cause analysis and corrective actions (8D, DMAIC).
• Deep knowledge of quality methodologies such as FMEA (DFMEA & PFMEA) or MSA & SPC.