Associate Quality Engineer – US Operations

About the role

The Interventional Urology Operations Associate Quality Engineer supports and maintains quality compliance within US Operations, with a primary focus on patient safety and product quality.

Key responsibilities

• Provide Quality Engineering support to ensure FDA/ISO compliance and act as first‑line support for quality issues.
• Quarantine and disposition non‑conforming product and own non‑conformances, including root‑cause analysis.
• Participate in Material Review Board (MRB) meetings and lead corrective and preventive actions as needed.
• Prepare, review and approve quality documentation such as SOPs and work instructions.
• Support change controls, complaint investigations and continuous‑improvement initiatives.
• Perform data analysis, write summary reports and maintain applicable QMS instructions.

Required profile

• Bachelor’s degree in engineering or a related field.
• 0–2+ years of manufacturing or related work experience.
• Self‑motivated, able to work independently in a collaborative team.
• Strong analytical and problem‑solving abilities.
• High‑performing individual who embraces challenges and opportunities.

Required skills

• Excellent written and oral communication with strong technical writing.
• Proficiency with Microsoft Office Suite (Access, Word, Excel, PowerPoint).
• Strong decision‑making, troubleshooting and problem‑solving skills.
• Ability to interact professionally with internal and external customers/vendors.
• Understanding of FDA, QSMR, ISO 13485 and ISO 14971 requirements.

What we offer

• Comprehensive health, dental and vision insurance, wellness programs and generous parental leave.
• Competitive 401(k) with immediate company match, financial planning services and corporate discounts.
• Generous paid time off, flexible work hours and possible flexible work arrangements.
• Continuous learning opportunities, mentorship, tuition reimbursement and career advancement programs.
• Recognition programs, bonuses, awards and special events.
• Supportive community culture with team‑building, volunteer activities and sustainability initiatives.
• Competitive salary range $73,767 – $110,650 plus potential bonuses or incentives.