Global Design Quality Engineer - Medical Devices

RXinsider LTD.; Canada; On-site; CAD 155,000 - 258,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Career development programs

Tuition reimbursement

Job summary

Dexcom is seeking a Staff Design Quality Engineer (Global Expansions) to drive design control, risk management, and regulatory compliance across international markets. You will ensure local design requirements integrate into Dexcom’s global product lifecycle.

The role leads quality activities for global expansions, collaborates with cross-functional teams, and communicates effectively with regulators and internal stakeholders to maintain high product quality and compliance.

Qualifications

• Bachelor’s degree in a technical discipline with 8–12 years related experience or Master’s degree with 5–7 years equivalent industry experience or PhD with 2–4 years experience.
• Bachelor’s/Master’s/PhD in a technical field as applicable to medical device development.

Responsibilities

• Serve as SME aligning Design History Files (DHFs) with regulatory requirements of target international markets.
• Lead Quality Lead role assessing impact of change controls, CAPAs and Non-Conformances on the system.
• Lead regulatory agency requests as part of global expansions.
• Support investigations from CAPAs and complaint investigations.
• Identify, prioritize, communicate, and resolve quality issues.

Skills

Design Quality Engineering

Medical device development

Global expansions

Cross-functional collaboration

Interpersonal communication

Self-motivated

Education

Bachelor’s degree in technical discipline

Master’s degree in technical discipline

PhD in technical discipline

Job description

Dexcom is seeking a Staff Design Quality Engineer (Global Expansions) to drive design control, risk management, and regulatory compliance across international markets. You will ensure local design requirements integrate into Dexcom’s global product lifecycle.

The role leads quality activities for global expansions, collaborates with cross-functional teams, and communicates effectively with regulators and internal stakeholders to maintain high product quality and compliance.