**Primary Duties and Responsibilities**:
- Research, develop and implement projects, while lead internal, and/or external cross-functional teams-based process development and improvement efforts.
- Implement and maintain control mechanisms and systems to follow up, measure the impact, and receive feedback of already implemented projects.
- Responsible for defining documentation, processing times and KPIs of new and existing processes.
- Investigate and propose new ideas, process and systems to improve companies KPIs related to operational cost.
- Use statistical tools, problem solving, lean manufacturing, and improvement continue tools as required and his/her regular duties.
- Control and Lead improvements task and activities among cross functional departments
- Provide coaching and feedback to the designers and Staff members on main indicators trends.
- Send weekly report on trends that are found during their interactions while reviewing design treatment plans, clinical investigations, Manufacturing issues, and complaints from customers.
- Responsible for planning, implementing, and managing compliance of internal quality processes in alignment with external, quality and regulatory standards requirements.
- Performs analysis of quality system data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- Performs the role of Quality Assurance Reviewer/Approver for Quality System Documentation.
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
- Exercises independent judgment in methods, techniques, and evaluation criteria for obtaining results.
- Assist in recommending constructive ideas for improving scripts, programs, and processes.
- Networks with key contacts outside own area of expertise.
- Lead special projects as needed.
Address customer and team needs in a timely manner
**Job Requirements**:
LI-EU1
**REQUIREMENTS**:
- Bachelor's degree or internationally equivalent in Industrial Engineering, Quality engineering or other related fields
- Typically has 3-5 years of directly related experience
- Proficient in Microsoft Office Package
- Proficient in using Electronic Document Management Systems
- Experience in designing, execution, and measurement of quality processes
- Experience in investigation methodology and root cause analysis (5 Why's, Fishbone etc.)
- Experience in statistical analysis methodology / data analysis
- Prior work experience in healthcare (FDA) regulated industry; biotech, pharma, medical device.
- Travel Estimated overnight travel is 10%
- Advanced level of English Speaking, Reading, and Writing.
Strong effective oral and written communication skills with the ability to influence across the organization
**PREFERRED QUALIFICATIONS**:
- Proficiency in English is desirable for this position.
- A third language certification is a plus.
- Strong analytical skills with the ability to reason and influence at all levels in the value stream process.
- Ability to manage complexity and resolve conflicts that arise from balancing multiple priorities.
- Medical Device Regulatory Knowledge, ISO 13485, 21 CFR Part 820, ISO 14971
- Lean Manufacturing knowledge for process mapping, analysis and improvement.
**CERTIFICATIONS**
- Advance knowledge in Microsoft office suite.
- Tableau Knowledge
- LEAN SIX SIGMA GREEN BELT
**PREFERRED QUALIFICATIONS**
- Works on significant and unique issues where analysis of situations and data requires an evaluation of intangibles
- Identifies and sets strategic direction for large projects.
- Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results
- Creates formal networks involving coordination among groups
- Barriers to entry such as technical committee review exist at this level
- May contribute strategically
**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.
Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services.
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.