RAQA OpEx Senior Project Manager

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

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

Reports to Sr. Mgr. RAQA OpEx., with main responsibility to lead/support/collaborate with other Regulatory Affairs and/or Quality Assurance organizations to drive for maximizing efficiencies & achieve annual goals. Utilizing sound lean methodology and leveraging successful track record of related relevant accomplishments will be key for success.

Essential Job Duties

• Works with management to identify new process improvement opportunities in the areas of product and/or process quality, cost, performance, and preventive and predictive maintenance.
• Evaluates and analyzes current processes, metrics and performance to reduce process variation, improve process capabilities and optimize process performance.
• Develops process improvement initiatives to increase operational efficiency and productivity.
• Leads the deployment and implementation of new or changed processes to provide improved results.
• Potential assistance in managing capital projects.
• Prepares project presentations for management when needed.
• Leading/running Kaizen events.
• Applying robust lean methodology in various assignments including reduction in waste, improving product quality and maintaining compliance.

Qualifications

Required Skills and Experience

• Business Acumen - has demonstrated business knowledge and ability to display the linkage between projects and desired business results.
• Ability to navigate multiple projects with changing priorities and meet the projects deadlines.
• Ability to work with and influence peers and senior management.
• Leading or contributing to Business Excellence initiatives.
• Knowledge and hand on experience with Process improvement tools and methodologies (Lean, Six Sigma)
• Experience gathering/processing internal and external requirements.
• Technical aptitude and hands on Data analytics is required to collect and analyze data for determining improvement strategies.
• Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment.
• Strong verbal and written communication skills (including analysis, interpretation, & reasoning).

Required Education and Training

• Minimum bachelor’s degree in engineering or a related field.
• 10 years experience in a Quality organization, med device preferred
• Advanced degree (MBA, master’s in engineering or a related field) preferred.
• Black Belt or Green Belt Certification in Lean Six Sigma.
• ASQ certification (CMQ/OE) is a plus.
• Project Management hands on experience and certification is preferred.
• Knowledge of Quality Systems Regulations (21 CFR 820), ISO 13485 and ISO 14971 preferred.

Working Conditions

• Ability to travel up to 10% of the time.

Preferred Skills and Experience

• Previous experience in Medical Device manufacturing or Pharmaceutical environment is a plus.

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 Employme