Senior Software Quality Engineer

Dexcom; Seberang Perai; On-site; MYR 216,000 - 296,000; Full time

Job summary

A leading medical technology company in Penang, Malaysia, is seeking a professional to support quality activities and regulatory compliance for their Quality Management System. The ideal candidate will have a Bachelor's degree and possess expertise in software non-medical device regulations and quality management systems. This role offers opportunities for growth within a pioneering organization committed to innovation and quality, with a focus on teamwork and compliance in exciting projects.

Benefits

Comprehensive benefits program

Career development opportunities

Innovative work environment

Qualifications

• Experience in software non-medical device regulations (CFR Part 820, CSA)
• Direct experience with Quality Management Systems and risk management
• Intermediate to advanced experience in QMS activities

Responsibilities

• Maintain and create process documentation
• Support Quality audits as the System Matter Expert
• Ensure compliance with quality management systems

Skills

Quality Management Systems

Regulatory compliance

Collaborative work

Data migration planning

Risk assessments

Education

Bachelor’s degree

Job description

This role supports quality activities and projects to successfully meet department and corporate goals. Key contributor in support and collaboration for one or more areas of regulatory and IT compliance such as Quality Management System Regulation and Standards, System and functional risk assessments, validation plans and reports, Creating and maintaining Software Operating Procedures (SOPs), Process Instructions (PIs), and templates.

Where you come in:

You maintain and create process documentation

You support Quality audits as the System Matter Expert with the procedures

You as the system expert on system risks assessments

You communicate with small teams, peers, and management

You provide guidance and support defining the Quality Management System

You support new regulation gap analysis and updates to the Quality Management System

You support IT enterprise systems infrastructure, IT systems, implementation, deployment, post improvements, and maintenance

You ensure compliance with Domestic and International quality management systems

You support continuous improvement and review of the Quality Management System

You approve and review complex system test case scripts, automation scripts, approvals, and validation support

You provide guidance on data migration planning, scripting, and reporting.

You work closely with IT, Regulatory and Quality to ensure compliance with numerous agencies and requirements

You can assume job description reflects management’s assignment of essential functions, does not prescribe or restrict the tasks that may be assigned

What makes you successful:

You have experience in software non-medical device regulations (CFR Part 820, CSA, Validation for Non-Product Systems, ISO guidance and regulations)

You have direct experience with Quality Management Systems, Enterprise Computer Systems risk management and validations preferred

You can work collaboratively, able to work effectively with diverse functional groups

You must value and demonstrate diligence for compliance, as well as demonstrate technical competence and good judgement associated with each essential duty and responsibility

You have experience creating user needs and requirements

You must have intermediate to advanced experience with performing activities by creating and maintaining a Quality Management System

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%

Experience and Education Requirements:

Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience