Sr QA Engineer at Dexcom

Simpang Ampat, Penang, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

14 Apr, 26

Salary

0.0

Posted On

14 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Medical Device Experience, FDA Regulations, ISO 13485, Communication Skills, Presentation Skills, Organizational Skills, Planning Skills, Interpersonal Skills, Microsoft Office, Database Applications, Six Sigma, Lean Manufacturing, Total Quality Management, Auditing, CAPA, Document Control

Industry

Medical Equipment Manufacturing

Description

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. Meet the team: We are seeking a Sr. Quality Engineer who able to work in fast-paced environment. Possesses advanced knowledge of technical principles and theories, apply 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. Where you come in: You are 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. You design methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products. You perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. You may assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma). You are involved in reviewing, implementing, and maintaining quality assurance protocols and methods for processing materials into partially finished or finished products. You are involved in designing methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products. You may supervise and administer specific aspects of the quality system. You develop systems and perform 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. You perform internal audits to ensure systems consistently comply with requirements and are effective. You participate as a member of the design team. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs. You lead risk management, validation, sample size, and external standards review and implementation activities. You employ techniques like Six Sigma, Lean Manufacturing, and Total Quality Management to improve Dexcom operations. You improve systems and processes that enhance product safety; increase product consistency and conformance to requirements; improve production efficiency; and reduce operating and scrap costs. You coordinate the disposition of nonconforming materials with the Materials Review Board. You read, write, and understand specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools. You review schematics and mechanical drawings. You assume and perform other duties as assigned. What makes you successful: You have a Bachelor's degree and a minimum of 5-8 years of related experience; or a Master's degree and 2-5 years of equivalent industry experience. You have medical device experience preferred, and your knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality Management Systems) is highly valued. You have strong communication, presentation, organization, planning, and interpersonal skills necessary to work as a team member and act as a liaison with customers. Your proficiency in computer skills includes the use of Microsoft Office and database applications (e.g., Excel, Power BI, MiniTab/JMP), which is preferable. 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) 0-25% 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.

Responsibilities

The Sr. QA Engineer is responsible for planning, implementing, and managing compliance of manufacturing and production processes with safety, quality, and regulatory standards. This includes designing inspection methods, analyzing production data, and ensuring compliance with internal and external specifications.