Manager Quality Assurance at Dexcom

Simpang Ampat, Penang, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

01 Apr, 26

Salary

0.0

Posted On

01 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Document Control, Training Management, ISO 13485, FDA Compliance, Continuous Improvement, CAPA, Internal Audits, Management Reviews, Communication Skills, Organizational Skills, Problem-Solving Skills, Electronic Document Management Systems, Learning Management Systems, Risk Management, Lean Six Sigma

Industry

Medical Equipment Manufacturing

Description

Lead Document Control and Training Team Oversee the creation, review, approval, and maintenance of controlled documents within the Quality Management System (QMS). Ensure timely document revisions and compliance with regulatory and internal requirements. Manage training programs to ensure employees are trained on applicable procedures and standards. Champion mandatory quality training and a preventive quality culture; lead CI initiatives that simplify processes, strengthen compliance, and improve performance. Quality Management System (QMS) Oversight Ensuring compliance with ISO 13485, FDA, and other applicable regulatory standards. Maintain and improve QMS processes, including document control, training, CAPA, internal audits, and management reviews. Monitor QMS performance metrics and drive continuous improvement initiatives. Facilitate internal/external audit within the organization Regulatory and Audit Support Prepare for and support internal, external, and regulatory audits. Ensure readiness and compliance for inspections and certifications. Cross-Functional Collaboration Partner with Quality, Operations, and other departments to ensure alignment with QMS requirements. Provide guidance and training on QMS processes and compliance expectations. Minimum 10 years of experience in Quality Assurance within a regulated industry (medical device or pharmaceutical preferred). Strong knowledge of ISO 13485, 21 CFR 820, ISO 14971, and EU MDR; hands‑on audit hosting and inspection readiness Proven experience in document control systems and training program management. Demonstrated ability to lead teams and manage QMS processes effectively. Excellent communication, organizational, and problem-solving skills. Experience with electronic document management systems (EDMS) and Learning Management Systems (LMS). Familiarity with risk management, CAPA, and audit processes. Prior experience in a Quality Management System leadership role. Lean/Six Sigma or similar continuous improvement certification. Bachelor's degree in Quality, Engineering, Sciences, or related field. Advanced degree or professional certifications (e.g., ASQ CQE, CQA) is a plus.

Responsibilities

Lead the Document Control and Training Team to oversee the creation and maintenance of controlled documents within the Quality Management System. Ensure compliance with regulatory standards and drive continuous improvement initiatives.