PMS Quality Engineer
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Key skills for this role
Role Overview
The Post Market team works across Regulatory and Quality to understand product and process performance, assess issues, and execute robust resolutions.
The team supports safety and effectiveness improvements through investigation, communication, and quality-system execution.
Key Skills for This Role
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Primary Function
The Post Market team works across Regulatory and Quality to understand product and process performance, assess issues, and execute robust resolutions.
The team supports safety and effectiveness improvements through investigation, communication, and quality-system execution.
Essential Job Duties
- Process regulatory post-market complaint investigations and support responses to escalated field events.
- Partner with subject matter experts on complaint investigations, field events, and regulatory response letters.
- Support continuous process and quality improvement programs aligned with company standards and customer needs.
- Evolve processes and systems for timely escalation of product quality and compliance issues within a closed-loop quality system.
- Collect and analyze data, drive root cause analyses, and facilitate cross-functional issue resolution.
- Represent the Post Market Program in internal and external audits as necessary.
Required Skills and Experience
- At least 5 years of related experience in Quality, Engineering, Operations, or continuous improvement.
- Strong interpersonal and communication skills with the ability to present to broad audiences.
- Experience gathering and processing internal and external requirements.
- Ability to investigate product and process issues, solve problems creatively, and document findings.
- Ability to collaborate with product and process subject matter experts in cross-functional teams.
- Technical aptitude for data collection and analysis, managing changing priorities, and meeting project timelines.
- Ability to travel up to 10% of the time.
Education and Preferred Qualifications
- Bachelor's degree in Engineering or an equivalent field is required.
- Knowledge of Quality Systems Regulations, including 21 CFR 820, and ISO 13485 is preferred.
- Lean or Six Sigma process-improvement knowledge is preferred.
- Green or Black Belt certification and project management experience are a plus or preferred, respectively.
About Intuitive
Intuitive develops robotic-assisted surgery and minimally invasive care technologies, including the da Vinci surgical system and Ion, to improve surgical outcomes.
About intuitive
Global leader in robotic-assisted and minimally invasive surgery.
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