What are the responsibilities and job description for the Sr Continuous Improvement Quality Engineer (CAPA Lead) position at Intuitive?
Company Description
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
Primary Function of Position:
The Post Market team at ISI 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 within the Post Market team include Post Market Surveillance, Field Action, Data Analytics, Clinical Engineering, Failure Analysis Engineering, and Continuous Improvement Quality 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 Continuous Improvement Quality Engineering Team requires a Sr. Continuous Improvement Quality Engineer with strong, hands-on experience in problem solving, technical savvy with complex electro-mechanical devices, and passion for the best practices to analyze, monitor, and improve product and process.
Roles & Responsibilities:
- Reporting to the Sr. Manager, Continuous Improvement Quality Engineering, the Sr. Continuous Improvement Quality Engineer is responsible for creating and supporting a quality culture by driving compliance activities around the CAPA Program, partnering across the organization to manage continuous process/quality improvement programs that strongly align with ISI standards and customer needs while meeting all applicable Medical Device Regulations and Standards. S/he will partner with subject matter experts on various corrective and preventive (CAPA) activities in addition to supporting other improvement initiatives. S/he will evolve existing processes/systems to ensure timely escalation identification of product quality & compliance issues within a closed loop quality management system.
The CIQE 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. S/he will participate in internal/external audits as necessary representing the CAPA Program.
Qualifications
Skills, Experience, Education, & Training:
- Minimum Bachelor’s degree (Engineering or equivalent) combined with minimum 6-8 years of related experience in Quality, Engineering, Operations, or a continuous improvement environment.
- Expertise of Quality Systems Regulations within Medical Device or related industries following (21 CFR 820) and ISO 13485.
- Experience leading and owning CAPAs.
- Experience gathering and presenting quality data for reporting and presenting CAPA metrics/KPIs.
- Strong interpersonal and communication skills:
- Passionate about making products and processes better.
- Quality/Compliance focus and attention to detail.
- Critical thinking skills for analyzing risk, use of root cause analysis tools, and identifying improvements in a fast paced environment.
- Expertise in GMP and CAPA Documentation.
- Able to assist people in finding creative solutions around constraints.
- Able to deliver presentations to a broad audience.
- 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 drive creative problem solving related to product and process issues.
- 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.
Preferred Skills:
- ASQ certification (CQE) is a plus.
- 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.
- CAPA Review and Approval.
- Project Management experience preferred.
Shift: Shift 1 - Day
Travel: Yes, 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.
