Available job openings

Quality Engineer – Risk Management

The Quality Engineer – Risk Management position reports to the Quality Manager.  This position controls and ensures appropriate risk management through the organisation;

Duties and Responsibilities

The job holder’s duties or responsibilities are not limited to those listed below. The job holder is expected to perform other duties and responsibilities as assigned by the Quality Manager.

The job holder’s duties & responsibilities include any of the following:

  • Assists in establishing, implementing and maintaining the Quality Management System (QMS);

  • Supports engineering projects by providing quality engineering – risk management input pertaining to new products as well as existing products in manufacturing (PFMEA);

  • Coordinate and leading the processes regarding risk assessment activities related to product complaints, 

  • Collate and prepare documentation required for risk assessment meetings and coordinate sign-off activities.

  • Create and maintain risk management files in line with Quality Management System (QMS), and the appropriate International Standards including compliance to the Medical Device Directive (MDD);

  • Collects, analyzes and reports key (quality) performance indicators to key stakeholders (internal and external);


Minimum Qualifications

These are only minimum qualifications for this position at this grade level. Other factors are taken into consideration when deciding what position and grade level to place an employee such as performance level, capable contribution level and company need.

  • Basic engineering degree plus 5 years or more quality engineering risk management experience within the medical technology industry or equivalent, or equivalent combination of education and experience; ASQ CQE certification preferred;

 

Specific Skills & Abilities

  • Sound knowledge of ISO 13485, ISO14971 and Medical Device Directive requirements;

  • EN62304 and appropriate software standards;

  • Good written and oral communication (Hebrew and English preferred);

  • Good prioritizing, organization, interpersonal, communication and analytical skills;

  • Work independently with minimum supervision;

  • Good computer skills (MS Office);

  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form;

  • Sound knowledge of US FDA 21 CFR 820 requirements preferred

To apply for this position e-mail jobs@cme-infusion.com​ with your resume and the title of this position.

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