Regulatory Post Market Surveillance Quality Engineer

Company Description

Job Description

Primary Function of Position:

The Post Market team at Intuitive works at the intersection of Regulatory and Quality. The team engages across the organization to deeply understand how our products and processes perform, the implications of any issues, and support the execution of robust resolutions. Functions collaborating with the Post Market team include Post Market Surveillance, Field Action, Data Analytics, Clinical Engineering, Field Service, Technical Support, Customer Service, Risk Management, Service Operations, and Failure Analysis Engineering. The Post Market Team advocates for safety and effectiveness improvements by assessing field product performance and QMS processes to identify, investigate, communicate, and execute on opportunities. The Post Market team requires a Quality Engineer with strong hands-on experience in problem solving, technical savvy with complex electro-mechanical devices, proficient technical writing ability and passion for the best practices to analyze, monitor, and improve both product and process.

Roles & Responsibilities:

• Reporting to the Sr. Manager, Regulatory Post Market Surveillance, the Regulatory Post Market Surveillance Quality Engineer (RPMS QE) is responsible for processing Complaint Investigations; partnering across the organization to identify and support continuous process/quality improvement programs that strongly align with Intuitive standards and customer needs while meeting all applicable Medical Device Regulations and Standards.
• Partner with subject matter experts on various activities related to complaint investigations, escalated field events, or regulatory response letters.
• Evolve existing processes/systems to ensure timely escalation identification of product quality & compliance issues within a closed loop quality management system.
• The RPMS QE will work to collect and analyze data, drive rigorous root cause analyses and facilitate cross-functional discussions to ensure we are seeing 'all the way around' issues for complete resolution.
• Participate in internal/external audits as necessary representing the Post Market Program.

Qualifications

Skills, Experience, Education, & Training:

• Minimum education: Bachelor's degree (Engineering or equivalent) combined with minimum 3 years of related experience in Quality, Engineering, Operations, or a continuous improvement environment.
• Must have working experience of Quality Systems Regulations (21 CFR 820) and ISO 13485.
• Strong interpersonal and communication skills:
  • Passionate about making products and processes better
  • Able to assist people in finding creative solutions around constraints.
  • Able to deliver presentations to a broad audience
• Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred. Green or Black Belt Certification in Lean or Six Sigma is a plus.
• Experience gathering/processing internal and external requirements.
• Business Acumen - has demonstrated business knowledge and ability to display the linkage between projects and desired business results.
• Proven ability to investigate issues and drive creative problem solving related to product/process issues and effectively document as needed.
• The ability to collaborate effectively with product and/or process subject matter experts in a cross-functional team environment is required.
• Technical aptitude is required to collect and analyze data for determining an improvement strategy.
• Ability to navigate multiple projects with changing priorities. Ability to execute to project timelines. Project Management experience preferred.
• Ability to travel up to 10% of the time.

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 Employment 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.

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.

Base Salary Range Region 1: $109,100 - $157,100
Base Salary Range Region 2: $92,700 - $133,500
Shift: Day
Travel: None
Workplace Type: Purposeful Onsite - This job requires being onsite for leader-defined events and activities which could be monthly/annually. Onsite frequency may increase based on business need.