QA Engineering Mgmt 3

Position Summary:

We are seeking a highly motivated and experienced Quality Engineering Manager to lead and support quality engineering activities for the development manufacturing and post-market support of medical devices. The ideal candidate will ensure products are designed and manufactured in compliance with FDA 21 CFR Part 820 ISO 13485 and applicable regulatory requirements. This role is critical to maintaining product quality patient safety and regulatory compliance across the product lifecycle.

Key Responsibilities:

• Lead and manage a team of Quality Engineers responsible for design assurance process product and equipment validation risk management and CAPA.
• Provide quality engineering support throughout the product lifecycle from concept through commercialization and post-market activities.
• Lead risk management activities per ISO 14971 including FMEAs and fault tree analysis.
• Oversee design control documentation and support DHF reviews to ensure regulatory compliance.
• Develop and implement process validation protocols (IQ/OQ/PQ) for new and existing manufacturing processes.
• Partner with R&D Manufacturing Regulatory Affairs and other cross-functional teams to support product development and sustaining engineering efforts.
• Drive root cause analysis and corrective/preventive actions (CAPA) for product and process nonconformances.
• Participate in internal and external audits (FDA ISO MDSAP) including preparation and response.
• Establish and report on quality metrics/KPIs; monitor trends and recommend improvements.
• Provide training and mentorship to the quality engineering team and broader organization on quality standards and best practices.

Qualifications :

Required Qualifications:

• Bachelors degree in Engineering Life Sciences or related technical discipline; advanced degree preferred.
• 7 years of experience in quality engineering or quality assurance in a medical device or regulated industry.
• 24 years of experience in a supervisory or managerial role.
• In-depth knowledge of ISO 13485 FDA QSR (21 CFR Part 820) and risk management principles (ISO 14971).
• Strong background in design control product verification/validation and process validation.
• Proficiency in quality tools such as root cause analysis FMEA SPC and statistical analysis.
• Excellent communication project management and leadership skills.

Preferred Qualifications:

• Certified Quality Engineer (CQE) Six Sigma Black Belt or similar certification.
• Experience with software as a medical device (SaMD) or combination products.
• Working knowledge of EU MDR and global regulatory requirements.

Working Conditions:

• Office and occasional cleanroom/manufacturing environment.
• Occasional travel may be required (<10%).

Why Join Us

• Work with innovative products that improve lives.
• Collaborative and growth-oriented team culture.
• Competitive salary bonus structure and benefits package.

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Remote Work :

No

Employment Type :

Full-time