Sr QA Engineer

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

We are seeking a Sr. 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, support external audits and drive closure of corrective actions.
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.
Able to review and understand schematics and mechanical drawings. Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
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.
Proficiency with statistical tools (Minitab, JMP, or equivalent) and hands-on experience in root cause analysis and corrective actions (8D, DMAIC)

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

Details

Location

Penang, Malaysia

Experience

Min. 5 years

The Company

Summary

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, support external audits and drive closure of corrective actions.
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.
Able to review and understand schematics and mechanical drawings. Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
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.
Proficiency with statistical tools (Minitab, JMP, or equivalent) and hands-on experience in root cause analysis and corrective actions (8D, DMAIC)