QA Specialist (Metrology Specialist)
- Costa Rica
- Permanente
- Tiempo completo
ATL Technology is seeking a Quality Specialist (Metrology) to manage and improve Quality Management System processes including document control, change control, training, NPI, and records management. This role ensures compliance with FDA-regulated, internal, and externally certified quality system requirements. The position collaborates with cross-functional site leadership and global teams to enable continually improved results for customers, colleagues, and the company.Duties and Responsibilities
- Administer Document Control and Change Control systems
- Review and manage electronic documents in the QMS system
- Support NPI and product transfers, including reporting and tracking
- Create routines in optical and vision systems or other automatic measurement equipment
- Train individuals on dimensional and geometrical tolerances and measurement equipment
- Co-host customer and regulatory audits
- Maintain IOUD/Deviation logs and contribute to CAPA, complaints, NCMRs, and SCARs
- Support engineers with GD&T and measurement recommendations
- Perform other duties as assigned
Education & Experience
- Bachelor's degree in engineering or related field (or 5 years of equivalent experience)
- 1+ years in the medical industry or equivalent
- 2+ years using dimensional measurement tools and vision systems
- Knowledge of 21 CFR 820, ISO 13485, and ISO 14971
- Fluent in English (spoken and written)
- Proficient in GD&T and drawing interpretation
- Experience with automated vision systems and coordinate-measuring machines
- Strong analytical and problem-solving abilities
- Proficiency in MS Excel, Word, and PowerPoint
- Experience in statistical/data analysis and report writing
- Ability to interface effectively across teams and with customers
- Occasionally required to stand, walk, and lift up to 25 pounds
- Frequently required to sit, use hands, and communicate clearly
- Ability to focus visually and work in moderate noise environments
ATL Technology is a global leader in custom interconnect solutions for medical devices. We specialize in design, development, and manufacturing of high-quality, reliable products that improve patient outcomes. Our collaborative culture and commitment to innovation make ATL a great place to grow your career.Diversity Statement
At ATL Technology, we value diversity and inclusion. We are committed to creating an environment where all employees feel respected, supported, and empowered to contribute to our mission. We welcome applicants from all backgrounds and experiences.Job Posted by ApplicantPro