Staff Design Quality Engineer (Global Expansions)

About the role

For our client, we are seeking a Staff Design Quality Engineer (Global Expansions) to join the team of a leader in the Healthcare space. This role will serve as a key quality engineering partner supporting global expansion efforts for medical device development. The successful candidate will help ensure design control rigor, compliance readiness, and effective resolution of quality issues across change management and post-market activities. This position also interfaces closely with regulatory stakeholders and cross-functional teams to strengthen quality outcomes in a highly regulated environment.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Serve as the subject matter expert for Design History Files compliance
• Lead quality assessments of change controls, CAPAs, and nonconformances
• Act as the primary quality contact for regulatory agency requests
• Support investigations stemming from CAPAs and complaint investigations
• Identify and resolve quality issues effectively

Qualifications

• Minimum 8+ years of experience in medical device development
• At least 5+ years leading global expansions in medical device development
• Proven expertise in Design Quality Engineering and Assurance within the industry
• Bachelor's degree in a technical discipline, or an advanced degree with reduced experience
• Exceptional communication and collaboration skills

Benefits

• Front row seat to life-changing CGM technology
• Comprehensive benefits program
• Global growth opportunities
• Career development through learning programs and tuition reimbursement
• Innovative and employee-focused organizational culture

Pay

$111,100 – $185,100 annually