Sr. Production and Suppliers Quality Engineer (QA Specialist)

Department: Quality

Location: EMEA-Israel

Description

About this opportunity

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.

Skills, Knowledge & Expertise

In this role, you’ll need …

Bachelor’s 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

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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.

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