Quality Support 2 at Dexcom

Simpang Ampat, Penang, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Compliance, Root Cause Analysis, Continuous Improvement, ISO Standards, Microsoft Office, ERP Systems, Communication, Adaptability, Audit Support

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: Assist with the day-to-day operations associated with Control of Nonconforming Materials. Assist management to ensure that products, procedures, and processes comply with applicable regulations and standards. Where you come in: You manage the daily operations of the Quality Assurance team to ensure adherence to company standards and regulatory requirements. You monitor product quality and implement corrective actions to maintain compliance with specifications. You lead root cause analysis and drive continuous improvement initiatives to enhance product reliability. You review and approve quality documentation, reports, and audit findings for accuracy and completeness. You collaborate with cross-functional teams to resolve quality issues and support new product introductions. You train and mentor team members to strengthen technical skills and ensure consistent application of quality procedures. You ensure compliance with ISO standards and customer requirements through regular audits and process evaluations. You report key quality metrics to management and recommend strategies for improvement. What makes you successful: You have a minimum of 3 years of experience working in the medical device, pharmaceutical, or other regulated industry within the Quality Assurance department. You understand Quality Management Systems (QMS) as applied to medical devices and can ensure compliance with regulatory standards. Your proficiency includes Microsoft Office tools and ERP systems for documentation and reporting. You communicate effectively and clearly across teams and stakeholders. You work hands-on in a fast-paced environment and adapt quickly to changing priorities. You can flex your schedule and work different shifts to support commercial production runs. Your experience includes working with global regulatory standards (FDA, EU MDR) and supporting audits. You have exposure to additional systems such as SAP or other advanced ERP platforms. 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: 0-5% 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

Manage daily operations of the Quality Assurance team to ensure compliance with company standards and regulatory requirements. Monitor product quality, implement corrective actions, and collaborate with cross-functional teams to resolve quality issues.