Quality Engineer II
ATL Technology
San Rafael District, Alajuela, Costa Rica
Quality Assurance / Control
Ensure product and process quality during manufacturing transfers (NPI, site transfers, supplier transfers) and throughout the sustaining phase by implementing, maintaining, and continuously improving quality systems, change management, risk management, and problem-solving activities, in compliance with applicable regulations and customer requirements.
Key Responsibilities
Manufacturing Transfers
- Actively participate in manufacturing transfer projects (NPI, inter-site transfers, supplier transfers).
- Ensure quality requirements are properly defined, transferred, and validated.
- Review and approve transfer-related documentation such as PFMEA, Control Plans, IQ/OQ/PQ, SOPs, BOMs, and process flows.
- Coordinate quality activities with cross-functional teams (Engineering, Operations, Supply Chain).
- Identify and mitigate quality risks associated with process, site, or supplier changes.
- Support internal, customer, and regulatory audits related to transfers.
- Provide ongoing quality support to manufacturing lines to ensure compliance with product specifications and quality KPIs.
- Lead or support nonconformance investigations, CAPAs, and root cause analyses (8D, DMAIC, 5 Whys).
- Evaluate and approve Engineering Change Requests/Orders (ECR/ECO/ECN).
- Analyze quality trends (scrap, rework, complaints, yield) and drive continuous improvement actions.
- Ensure proper maintenance and continuous improvement of quality system documentation.
- Support supplier quality activities (SCAR, PPAP, incoming inspection controls).
Education
- Bachelor’s degree in Engineering (Industrial, Mechanical, Manufacturing, Biomedical, Electronic, or related discipline).
- 3–5 years of experience in Quality Engineering or related roles.
- Demonstrated experience in manufacturing transfers and sustaining support.
- Experience working in regulated industries (ISO 9001, ISO 13485, IATF 16949 preferred).
- Quality tools: PFMEA, Control Plans, SPC, MSA, PPAP.
- Strong root cause analysis and problem-solving skills.
- Change management and document control.
- Process validation (IQ/OQ/PQ).
- Internal and external audits.
- Quality metrics and KPI management.
- Intermediate to advanced English (technical reading, writing, and communication).
- Analytical thinking and structured problem-solving.
- Ability to manage multiple priorities and projects.
- Effective communication with cross-functional teams.
- Strong attention to detail and regulatory compliance mindset.
- Continuous improvement orientation.
- Ability to work independently and escalate risks appropriately.
- Timely and effective CAPA closure.
- Post-transfer quality performance.
- Reduction in defects, scrap, and rework.
- On-time completion of transfer and NPI milestones.
- Audit performance and compliance results.
About the company
Company website•Medical Equipment Manufacturing
Improving Lives through Medical Device Innovation.
At ATL Technology, we are the trusted partner of choice for leading medical device OEMs worldwide. With over 30 years of expertise, we excel in designing, developing, and manufacturing innovative medical devices that improve and save lives.
Our commitment to engineering excellence and unwavering dedication to quality drive us to deliver cutting-edge solutions across various medical fields. From electrosurgical instruments and camera-based imaging devices to high-density interconnect technologies, we offer a wide range of specialized products and services.
Our vertically integrated capabilities empower us to collaborate with OEMs at any stage of development, from concept to mass production. We pride ourselves on fostering innovation through robust partnerships and comprehensive support, ensuring our customers' success in an ever-evolving healthcare landscape.
At ATL Technology, we understand that it's not just about technology; it's about the people behind it who drive real change in healthcare. Join us in our mission to protect and enhance lives through groundbreaking medical device innovation.
Innovation. Expertise. Excellence. ATL Technology.