Process Design Analyst
hace 2 semanas
Process Design Analyst II is responsible to ensure that all digital processes for treatment planning are aligned with the Quality management system.
It monitors and assesses Digital Production cases for quality, efficiency, and performance maintenance and improvement. Provides execution of tasks with speed and great quality for the overall agility of the software quality team.
Will align and prioritize along with Operations Managers, the productivity improvement projects, standard work implementation, and other initiatives that support efficient use of resources.
- Identify improvements in the value streams and creates and deliver the vision for pullbased workflows through those value streams.
- This position will support peers and engineers as required.
- The position will be responsible for facilitating, training, and developing the Continuous Improvement process and culture.
- Provides oversight and direction on continuous improvement projects.
- Teaches Lean concepts for every cycle of Leadership development including the CI practitioner certification program.
- Ensures compliance with ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpreting regulations, performing a gap analysis, and leading activities to implement improvements.
Job Requirements:
- Bachelor's degree or international equivalent in Industrial Engineering, Quality engineering, or other related fields
- Prior work experience in healthcare (FDA) regulated industry; biotech, pharma, medical device.
- Advanced level of English Speaking, Reading, and Writing. Strong effective oral and written communication skills with the ability to influence the organization
Travel
- Estimated overnight travel is 10%
PREFERRED QUALIFICATIONS:
- Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate, and empower others.
- Must have a demonstrated ability to lead continuous improvement initiatives across a complex matrix organization, execute on agreedupon improvement plans, and drive change management
- Demonstrated Lean Manufacturing Knowledge.
- Working knowledge of and experience with U.S. FDA regulations, ISO 13485 Quality System Standard, ISO 14971 Risk Management
- Strong written, verbal, and presentation skills
- Advanced English level
Operating Company:
Spark
About Envista:
Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives.
Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile.
Envista companies, including KaVo, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.
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