Quality Engineer

hace 3 semanas

San José, Costa Rica Spark A tiempo completo

We know that dental professionals do more than create healthy, beautiful smiles—they create confidence. To achieve their goals, they need a champion. They need someone who will be there for them, side by side and end to end.

At Envista, we’re uniquely positioned to be this champion. Our differentiated combination of continuous improvement, a bias toward action, a deep respect for the professionals we serve, and innovative products and services embolden us to champion dental professionals like no one else can. Our comprehensive product portfolio 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 partner with dental professionals to help them deliver the best possible patient care.

**ROLE OVERVIEW/SUMMARY**:
Quality Engineer is responsible for insuring that all digital treatment planning processes align with the Quality management system. It monitors and assesses Production cases for quality, efficiency, and performance maintenance and improvement. Provides execution of QA tasks with speed and great quality for the overall agility of the QA team.

Create and implement new regulatory standard operating procedures, and/or propose revisions and/or act as a reviewer for regulatory standard operating procedures, as assigned and appropriate.

**PRIMARY DUTIES AND RESPONSIBILITIES**:

- Responsible for planning, implementing, and managing compliance of internal quality processes in alignment with external, quality and regulatory standards requirements.
- In charge of establishing good documentation practices and processes in each Design operation or department within the quality management system.
- Provide coaching and feedback to the designers and Staff members on QA main indicators trends.
- This position may have people in charge, who will coach, and support peers' engineers as required.
- Send weekly reports on trends found during their interactions while reviewing design treatment plans, clinical investigations, Manufacturing issues, and customer complaints
- Provides support to business entities aligning and adopting Quality Policies/Processes.
- Performs analysis of quality system data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- 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**:
**REQUIREMENTS**:

- Experience in Medical Device Regulatory Knowledge in the Clear Aligners industry (ISO 13485, 21 CFR Part 820, ISO 14971)
- Proficient in Microsoft Office Package
- Proficient in using Electronic Document Management Systems
- Experience in designing, executing 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
- Excellent Verbal and Written Skills (English), and interpersonal skills

**PREFERRED QUALIFICATIONS**:

- Experience in risk management (Risk Assessment / FMEA) - ISO 14971
- Strong analytical skills with the ability to reason and influence at all levels in the value stream process.
- Lean Manufacturing knowledge for process mapping, analysis and improvement.

**CERTIFICATIONS**
- Bachelor's degree or internationally equivalent in Industrial Engineering, Quality engineering or other related fields
- Typically has 2 - 3 years of directly related experience.
- 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 the 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 a

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