Quality Engineer

*NPD Quality & Compliance Engineer* (020)

An International Medical Device company Located in Yoqneam (North Israel) is looking for a NPD Quality & Compliance Engineer

*Summary*

This position ensures the Company develops products in compliance with quality assurance systems throughout the product lifecycle. Responsibilities include product development, adherence to QA standards, internal and external audits, and coordination with external quality assurance organizations.

*Duties & Responsibilities*

Quality Product Development (Class III):

Oversees product development processes for compliance with standards and regulations.

Implements methodologies and initiates improvements to quality assurance processes.

Leads risk management, problem investigation, and escalation of potential risks or safety issues.

Manages design controls, quality activities during product development, and product transfer from R&D to production.

Leads design changes and assessments.

Implements quality processes and standards for new product introduction.

Maintains quality plans and metrics, presenting product status updates.

Leads quality investigations and escalates product issues.

Quality Development of Tools and Jigs

Leads quality activities for tool and jig development.

Analyzes and reviews approval processes for test equipment.

Class III Design History File (DHF) Management

Manages DHFs for Class III products.

Provides QA support in R&D Class III projects.

Defines project deliverables list.

Manages and approves project deliverables.

Performs credibility checks for project deliverables.

Oversees development process compliance with external quality processes.

Updates DHF content based on the development process and Agile phases.

Ensures compliance with relevant standards for software development processes (Class III).

QA Compliance

Functions as the QA representative for compliance with all company and industry New Product Development (NPD) standards.

Performs product and NPD process internal audits and oversees preparation for external audits.

Ensures project teams are aware of and comply with relevant standards and processes.

Leads design problem investigations.

Defines and maintains project design status.

General

Communicates business issues and opportunities to management.

Ensures personal and company compliance with regulations, policies, and procedures.

Performs other assigned duties as needed.

*Experience & Education*

Bachelor of Science in Engineering preferred, or another degree with Quality qualification.

Qualification in Quality Assurance (CQE, CSQE, CQM, CRE) – a plus.

Experience as a Quality Engineer, preferably in a medical device company with Class III devices – a plus

Experience in quality methods in product design.

Strong understanding of ISO standards & Regulations (13485, 14971, MDD, MDR).

Excellent interpersonal skills.

Ability to work effectively with remote management.

Strong written and spoken English skills.

Self-confidence and integrity.

Self-motivated and project-oriented, with the ability to work independently and collaboratively.

Strong communication skills (verbal and written).

Strategic thinking and results-oriented.

Ability to see the big picture while maintaining attention to detail.