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.
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.
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.
