Primary Function of Position:

• Accountable for Quality Improvement Project (QIP) completion and ongoing sustainment and improvement of Production & Process Control processes and procedures to ensure scalability and effectiveness.
• Drive efforts to finalize the new process (in flight).
• Work with the Business Units (BU's) to develop the strategic roadmap for processes and procedures continuous improvement, head the development and implementation plan, secure resources, and complete projects.
• Define long-term accountabilities and serve as business manager for Production and process controls.
• Oversee updates of SOPs, Instructions, or business processes and associated training plans.
• Is the SME for Production and process control. Represent Intuitive during Internal and External Audits.
• Will be the owner of any associated audit findings in production and process control.
• Accountable for production and process control QMS processes.
• Heads up production and process control working team; guide a cross-BU team of stakeholders through influence.
• Has formal reporting responsibilities to Operations.
• Manage curriculum-based training program for production and process control.
• Evaluate and enhance the effectiveness of the training program to ensure that all affected teams have the necessary knowledge and skills to perform their work successfully.

Roles & Responsibilities:

• Continuously evaluate and optimize production and process control processes to enhance efficiency and effectiveness, especially as our business grows.
• Identify areas for improvement through process audits, feedback collection, and data analysis.
• Implement standardized work instructions and best practices to ensure consistent and streamlined execution across business units and global locations.
• Leverage automation tools and technologies to improve process efficiency and scalability.
• Foster a culture of continuous improvement by encouraging employee involvement and feedback in process enhancement initiatives.

Additional Accountabilities:

• Oversee QMS changes. Identify, maintain, and coordinate review and approval of changes.
• Review / Approve all production and process control QMS documents.
• Maintain the Approval Groups in Agile.
• Create a QMS roadmap that includes infrastructure needs (e.g., IT tools).
• Manage budget and headcount requests for these projects.
• Partner with other Process Owners to ensure effective QMS alignment and coordinate high-impact QMS changes across workstreams.
• Represent team in project team to implement system-level improvements.

• 12+ years of experience and a Bachelor’s degree; or 8+ years of experience and a Master’s degree; or equivalent experience
• 6+ years of experience in the medical device industry
• Experience leading multiple change management and transformation projects with effective rollout and training of new processes and procedures
• Experience in resolving audit findings and completing CAPAs
• Experienced in launching and maintaining medical device products
• Experience writing or executing process validation protocols
• Understanding IQ, OQ and PQ qualifications
• 20% domestic/international travel needed

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.