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Location: 

Haifa, IL, 3508504

Description: 

Supplier Quality Engineer

 

JOB SUMMARY:

The Supplier Quality Engineer in support of Novocure Supplier Quality and Supply Chain provides technical guidance and support to Novocure contract manufacturers and their suppliers in the areas of Medical Device Quality Assurance, Process Validation, Equipment Qualification and Quality Control.  This role ensures compliance to applicable regulatory requirements and procedures, while delivering to the objectives of applicable programs and strategic objectives, in alignment with both the Quality department and Supply Chain. The position contributes to a culture of Quality, teamwork and continuous improvement within the Operations business unit. In collaboration with business process owners, further develops product realization processes, ensuring stakeholder engagement and an effective process framework facilitating rapid and cost effective delivery of safe and effective products.

 

This is a full-time, exempt position located in Israel reporting to Novocure’s Associate Director, Global Supplier Quality

 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  1. Successful completion of the objectives assigned
    1. Works with other members of the QA organization and Supply Chain to deliver against strategic goals and improvement plans
    2. Expands and improves the implementation of LEAN and Six Sigma methodologies both within Novocure and at its contract manufacturers and sub-tier suppliers.
    3. Acts and represents Supplier Quality as part of the Supplier Qualification process

 

  1. For the suppliers he or she is in charge of,
    1. Ensure quality requirements are defined, implemented, maintained and monitored 
    2. Acts as QA approver for contract manufacturer and sub-tier supplier test plans, process changes, tooling changes, process validations and equipment qualifications.
    3. Ensure that for any deviation reported by Novocure (audit, complaint, NCMRs, others), a SCAR is efficiently implemented by the Supplier. If needed, support the supplier in the definition of the SCAR.
    4. For critical suppliers, conduct Monthly Quality Meetings to monitor Quality KPIs
    5. Attend to Quarterly Business Meetings
  2. For the process, he or she is in charge of
    1. If new, develop and implement the process.
    2. Ensure compliance to Novocure applicable requirements
    3. Maintain procedure – instruction applicable the process
    4. Report performance of the process during quarterly quality meetings or others
    5. Manage all deviations reported on the process
    6. Collaborates with contract manufacturers/sub-tier suppliers in the review of process changes and improvements, investigations and root cause analysis of process deviations, corrections, corrective actions, out of trends, and OOS as applicable.
    7. Optimize Improve the process
  3. Supplier Audits
    1. Conducts or support suppliers audits
  4. Attitude:
    1. Innovation, Focus, Drive, Courage, Trust and Empathy
  5. Specifics
    1. Travel requirement: 20%
    2. Support internal, corporate, notified body, FDA, and other audits. 
    3. All other duties as assigned.

 

QUALIFICATIONS/KNOWLEDGE:

  • Qualifications:
  • Minimum of a Bachelor degree, preferably in a Science or Engineering discipline, with applied Quality Engineering experience of 3-5 years

 

ISO 13485 Certified Lead Auditor or CQA and 6 Sigma and/or LEAN experience preferred Certification or demonstrated experience applying LEAN and six sigma principles and methodologies

 

  • Knowledge:
  • Supplier and QMS auditing experience in medical device, pharmaceutical or comparably regulated field
  • Demonstrated experience writing, evaluated and executing process validations..
  • Ability to navigate through ambiguity and rapid growth and adapt to change.
  • Ability to self-direct, and adapt to changing priorities
  • Outstanding communication skills (verbal and written in English).
  • Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment; comfortable working within international, multicultural teams.
  • Curious mindset, allowing continuous learning and comfort challenging the status quo.
  • At least four years previous experience in similar position
  • Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines.
  • Practical experience with Quality Risk Management, product lifecycle management (PLM) and process validation.

 

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

– innovation

– focus

– drive

– courage

– trust

– empathy

 

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