We are seeking a highly motivated and experienced Sr. Production and Quality Engineer to drive exceptional product quality, patient safety, and field reliability across the Installed Base (IB). This is a key technical role supporting production stability, RMA/DOA investigations, Automated Test Equipment (ATE) performance, and cross-functional quality engineering initiatives in a regulated medical device environment
Key Responsibilities
In this role, you will
Support RMA/DOA processes and continuous reduction of field failures.
Support qualifications and control of ATE testers in production lines.
Support ECO/ECR processes, NPI projects, product updates, and cross-functional engineering changes.
Work closely with R&D, engineering, manufacturing, and operations teams to enhance product quality and resolve technical issues.
Drive continuous improvement initiatives using tools such as Six Sigma, Lean, and Root Cause Analysis (RCA).
Participate in supplier selection and conduct suppliers audits.
Ensure compliance with ISO 13485, FDA 21 CFR 820, MDR, and other applicable medical device regulations.
Maintain and support quality documentation, including CAPA, Non-Conformance Reports (NCRs), and risk management documentation.
Requirements: Bachelors degree in Engineering (Mechanical, Electrical, Biomedical, or related field).
7+ years of experience in quality in medical device company
Strong analytical and problem-solving skills, including hands-on experience with RCA tools (5-Why, Fishbone, etc.).
Familiarity with ATE systems, V&V and process validations, production testing, and/or field reliability analysis - a strong advantage
Lead auditor of ISO13485, FDA 21 CFR 820, and ISO 14971 risk management.
Excellent communication and collaboration skills, with the ability to work effectively across functions.
A proactive, structured, and detail-oriented working style.
Fluent in English
This position is open to all candidates.