Quality Engineer

hace 2 semanas

Provincia de Cartago, Costa Rica Coloplast A tiempo completo

**Location**:
Cartago, Costa Rica, CR

**Job Family**: Quality Assurance

**Country/Region**: Costa Rica

Are you motivated by quality control of medical device products with the purpose of improving the lives of people with intimate health care needs?

We are looking for a committed, collaborative and experienced Quality Engineer to take up a position in our growing company. Your responsibility will be to ensure quality standards in the production of our medical device products before they reach the market. You will be a part of a growing quality team, as Coloplast is in the process of establishing a world-class manufacturing site in Cartago, Costa Rica.

You will report to Head of Quality, Coloplast Costa Rica Volume Manufacturing site, Cartago.

Key areas of responsibility

Provide quality engineering support to Operations value streams to ensure FDA/ISO compliance
Ensure compliance with Coloplast Quality Management system incl. creation, maintenance and execution of SOPs and WIs
Recommend and implement quality improvements of products/processes
Provide sparring/support to functions in Operations and Global Quality regarding quality issues, and help improve the overall quality understanding, and support of Lean activities
Participate and provide support in external and internal audits
Perform RCAs and handle NCs/CAPAs incl. handling of lot status in ERP system
Initiate and handle change control requests for product/process changes
Author and review process validation protocols and reports (IQ, OQ, PQ, DOE, process analysis/capability) incl. Process Risk Assessment / FMEA,
Author and review test method validation
Support Design Control and Risk Management processes
Training in Good Documentation Practice to production personnel, as well as training in quality procedures / tests

Your professional qualifications

Bachelor’s degree in Industrial Engineering, Quality, Production, Chemistry or equivalent
Minimum 2 years of experience within medical device manufacturing with thorough knowledge of methodologies of quality assurance and standards
Minimum 3 years of experience in Quality related roles
Knowledge of statistical/data analysis and report writing experience.
Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
Able to work to a high level with mínimal supervision.
Able to solve problems independently, take the initiative when required and anticipate needs.
English B2 level reading, writing, and speaking in a conversational level

As a person, you are ambitious, self-motivated and can work independently. You have the ability to focus on the details, as well as demonstrate problem-solving -, analytical -, and critical thinking skills. You are a collaborative team player with a positive can-do attitude, and with the ability to develop effective working relationship with colleagues.

Why Coloplast?

Coloplast develops products and services that make life easier for people with personal and private medical conditions. Working closely with the people who use our products, we create solutions that are sensitive to their special needs. We call this Intimate healthcare.

**We are guided by three values**:
**Closeness**: we work closely with our customers to find solutions that meet their specific needs.

**Passion**: we work passionately to create new and innovative products that improve the quality of life for our customers.

**Respect and responsibility**: we have deep respect for the private nature of the condition our customers face. Therefore, it’s our responsibility to find not only medical solutions, but also ways to minimize the trauma and taboo associated with these conditions.

Our business includes Ostomy Care, Continence Care, Urology Care, and Wound and Skin Care.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things.

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