Design Quality Assurance Engineer
Establishment Labs
full-time
Posted on:
Location Type: Hybrid
Location: Coyol • Costa Rica
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About the role
- Apply company policy and procedures
- Supports the design controls process during development of new medical devices or design changes including: Planning, Design requirements, Design Validation and Verifications, and Design transfer specifications.
- Support Design related root cause and corrective action investigations
- Lead the Usability Engineering activities including: Usability strategy plan, Usability strategy report, Formative and Summative Evaluations.
- Review and approve Engineering documentation, such as: Design controls deliverables, CAPAs, NCs, CCPs, etc.
- Coordinates the creation, review and updates of Risk Management Files and Reports for all applicable product families along with the Ops Quality and the Quality System departments.
- Other functions may be assigned by management based on his/her knowledge and experience.
Requirements
- Bachelor´s degree in Industrial Engineer, Industrial Production Engineer, Biomedical Engineer, Mechanic Engineer, Chemical Engineer, Material Engineer
- 2 years of Experience in Medical Industry within Quality Department
- Intermediate English (written & spoken)
- Team player
- Strong communication skills
- Analytical thinking
- Assessment Center: Please note the recruitment process for this role includes: initial interview, assessment center evaluation, hiring manager interview.
Benefits
- Equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability (visible and not visible), gender, gender identity or expression, or veteran status.
- Strive to be a more equal opportunity workplace.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Design controlsDesign requirementsDesign validationDesign verificationUsability engineeringRoot cause analysisCorrective actionRisk managementEngineering documentationQuality assurance
Soft Skills
Team playerStrong communicationAnalytical thinking
Certifications
Bachelor's degree in Industrial EngineeringBachelor's degree in Biomedical EngineeringBachelor's degree in Mechanical EngineeringBachelor's degree in Chemical EngineeringBachelor's degree in Material Engineering