Quality Assurance Engineer

hace 1 mes


Guaynabo, Guaynabo, Puerto Rico Systellar Technologies A tiempo completo

**Job Title:** Quality Assurance Engineer - Medical Device Lifecycle Management

 

**About Systellar Technologies**

Systellar Technologies is a leading company in medical device development, committed to delivering high-quality products that meet the needs of healthcare professionals and patients. Our team works collaboratively to ensure that our products are safe, effective, and reliable.

 

**Salary:** $120,000 - $150,000 per annum (dependent on location)

 

**Job Description:**

We are seeking an experienced Quality Assurance Engineer to join our team in medical device lifecycle management. The successful candidate will be responsible for ensuring compliance with FDA Quality System Regulations, EU MDR, and internal standards.

 

The ideal candidate will have experience in leading process improvement methodologies, such as Lean, Hoshin, or 6-sigma, and a good understanding of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820). A Master's degree in science, engineering, or a related field is required. PMP Certification is preferred.

 

**Required Skills and Qualifications:**

* Experience in leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma)

* Good understanding of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820)

* Knowledge of medical device process requirements

* Master's degree in science, engineering, or a related field

* PMP Certification preferred

 

**Benefits:**

* Competitive salary and benefits package

* Opportunities for professional growth and development

* Collaborative and dynamic work environment

 

**Others:**

This role offers a unique opportunity to work on exciting projects, collaborate with a talented team, and contribute to the development of innovative medical devices. If you are a motivated and experienced Quality Assurance Engineer looking for a new challenge, we encourage you to apply.



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