Quality Engineer

Department:
Quality

Location:
CRI-Costa Rica-Belen

Description
Role summary
This position is ideal for the target level of professionals to join the Quality Assurance Team as a
Quality Engineer,
responsible for developing, implementing, and maintaining the activities of the Quality Management System. Ensuring products and processes are designed with adherence to the Quality Management System.

Key Responsibilities
Role expectations

• Ensuring products and processes are designed with adherence to the Quality Management System.
• Responsible for planning, implementing, and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution.
• May assure compliance with in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).
• Oversee and coordinate all activities related to Internal Audits, ensuring they are implemented effectively and in a timely manner.
• Maintain accurate and complete records of all Internal Audit activities, including problem identification, root cause analysis, and follow-up on corrective actions.
• Perform data analysis to identify trends and areas for improvement, using statistical and quality tools.

Skills, Knowledge & Expertise
What we're looking for
Typically

• A bachelor's degree in Industrial Engineering or Business Administration is required, though a master's degree from a four-year college or university is considered an advantage.
• A minimum of 1 year of directly related experience as a Quality Engineer.
• Certification on ISO 13485:2016 as an internal auditor is required (Certificate as a Lead Internal Auditor is a plus).
• Proficiency in English is required for this position (B2+).
• Knowledge of MDSAP/FDA/EU MDR standards preferred is a plus.

Applicant Privacy Policy
Review our
Applicant Privacy Policy
for additional information.

Equal Opportunity Statement
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.