Quality Engineer

hace 4 meses

San José, Costa Rica Straumann Group A tiempo completo

About Straumann Group

Headquartered in Basel, Switzerland, the Straumann Group is a global leader in tooth replacement and orthodontic solutions that creates smiles and restores confidence. For more than six decades, we have been stretching the limits, entering new fields, and creating opportunities to make patients’ lives better. We are the leading independent player in our industry. From the first Dental Implant in 1974 to the latest Digital Solution - we do things different than others.

We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude.

WeChangeDentistry every day - and want you to be a part of it

**Summary** **of** **position**

Supports and implements systems in the areas of validation, advanced quality, risk management, change control, and design and development. Supports the development and enforcement of internal systems and procedures to meet the local Quality Management System, ISO standards, FDA quality system regulation, and other regulatory requirements. Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process. Specifies and implements new inspection equipment and instructs others in its proper use

**Essential** **functions** **and** **duties**
- Plans, executes, and reports on equipment and process validation.
- Assists with training on quality and compliance concepts and best practices.
- Work with Quality team and cross-functional teams to conduct quality investigations, identify root causes, and present potential solutions.
- Supports Treatment Planning teams in planning and execution of audits by external partners, regulatory authorities and/or their representatives.
- Creates and maintains the Risk Management program and works with internal team on risk mitigation strategies.
- Creates and maintains the change management program.
- Participates in the development, implementation, and reporting of metrics of interest to local operations, management, and external partners.
- Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area.
- Accurately records and reports of information as required.
- Follows employee policy within the company.

**Non-essential** **functions** **and** **duties**
- Attends Quality and other meetings as required
- Participates in additional training relevant to this position.
- Other duties may be assigned, directed or requested.

**Qualifications**

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill,and/or ability required.A reasonable accommodation may be made to ensure individuals with disabilities are able to perform the essential functions of the role.
- Bachelor's degree in quality, engineering and/or manufacturing fields preferred.
- Must have 3+ years quality control or quality assurance experience in medical device manufacturing field.
- Ability to work with multidisciplinary teams to execute projects,investigations, and training.
- Demonstrated ability to plan and work to robust timelines
- Experience in planning, execution and reporting of equipment and process validations
- Excellent understanding of quality principles and good documentation practices
- Familiarity with US and International medical device regulations and registrations.
- Must be familiar with and competent in conducting and managing Risk Management plans and summaries. Familiarity with ISO 13485 preferred.
- Knowledge of design control processes.
- Experience with managing non-conformances and CAPA.
- Front and back room audit experience.
- Must be able to utilize basic quality tools including RCA, Fishbone analysis, SPCs, FMEA, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts.
- Must be able to produce technical documents, testing and validation plans,IQ/OQ/PQ protocols and formal procedures.
- Six Sigma/Lean Manufacturing skills preferred.
- Must have excellent written communication skills
- Must have basic computer skills (Microsoft Office).

**Physical **requirements**:
The requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee:

- Will type on a computer keyboard, using a computer mouse and computer monitor for up to 8 hours at a time.
- Must be able to observe and hear warning signs and signals within all areas of the company.

**Language** **skills**

English at C1 level required

Ability to read and interpret training documents, safety rules, operating manuals, maintenance instructions and procedural documents.

**Mathematical** **skills**

Ability to calculate figures and m

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