Available job openings

Development Quality Engineer

As directed by the Quality Manager, the Development Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will support projects and tasks, from product inception through product launch and maintenance, and play an active role in the processes to ensure products meet quality standards consistently meeting all design control and other regulatory requirements.

 

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 input pertaining to Design Transfer to Production (DTP), Design Verification and Validation (V&V), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) activities;

  • Leads and/or supports process and/or product related failure investigations, establishes detailed failure investigation reports to faciliate timely implementation and/or closure of NCMRs, CAPAs and Customer Complaints;

  • Application of technical principles, theories, concepts, techniques and quality sciences / tools.

  • Develops solutions to routine problems.

  • Follows company procedures and makes basic procedural updates.

  • Developing working knowledge of applicable regulatory requirements.

  • Communicates across functions / departments for assigned areas of responsibility.

  • Is an extended team member representing Quality on new product development projects and a team member for sustaining engineering projects.

  • Provides audit support (preparation,  closure, etc. activities)

  • Position specific responsibilities include support of the following, however are not limited to:

    • Design Control     

    • Design Input

    • Design Output

    • Design Verification plans, protocols, and reports

    • Design Reviews

    • Design Validation

    • Design History File support

    • Change control 

    • Assessment of Change Request

    • Process Validations

    • Test method validations

    • Software validations

    • Proper Use of Statistics (Sampling Plans)

    • Advise on Regulations


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 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 and Medical Device Directive requirements;

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

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

  • Work independently with minimum supervision;

  • Sound knowledge of statistical techniques (e.g. Gage R&R, Acceptance Sampling, Process Capability, Statistical Process Control),

  • Sound knowledge of failure investigation techniques (8M, Cause and Effect Analysis);

  • Good computer skills (MS Office);

  • Basic knowledge of lean methods (5S, Lean Six SigmaSS, Kaizen) prefered;

  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists;

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

  • Sound knowledge of US FDA 21 CFR 820 requirements

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

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