Careers

Job Title: Sr. Supplier Quality Engineer

Location: Caesarea, Israel

Department: QA/RA

Reports to: QA Director

Job Description:  Leads the supplier quality engineering activities from design transfer trough production and post market product lifecycle. Partners with QA, R&D, engineering and supply chain functions to ensure quality and compliance of manufactured products.

Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

Key Responsibilities & Authorities:

Responsibilities :

• Leads contract manufacturers and supplier quality activities and monitors production and compliance key process indicators.
• Partners with R&D and Operations in supplier selection activities.
• Lead supplier evaluation and reevaluation activities.
• Develops and leads the supplier audit program.
• Performs supplier audits and monitors findings closure.
• Leads the Supplier Corrective Action program.
• Leads supplier quality reviews
• Supports new product introduction activities including process, equipment, SW and environment validations, production risk management, control plans component qualification and staff training.
• Utilizes advance statistical tools and practices to analyze and improve production and product performance.
• Represent supplier quality in internal and external audits.
• Participles in Material Review Boards and communicates back to supplier.
• Support incoming inspection specification development.

Authorities:

• Approves supplier change requests.
• Approves finish medical device DHRs and lot release.
• Approves supplier’s deviations.

 

Education:

BCs in mechanical Engineering or similar discipline.

 

Experience Requirements:

• Minimum Experience: 5 years of quality experience in supplier/operational environment in medical device industry.
• Understanding and knowledge of medical device quality systems and standards.
• Suppliers auditing certificates and experience.
• Understanding of engineering change process.

 

Job Specific Skills (Languages, SW, systems, etc.'):

Excellent verbal and written communication skills (Hebrew and English).

Office proficient, experience and understanding of ERP, PLM, LMS, Doc Control systems.

 

Other Requirements for the role (% of travel, etc.):

Ability to work in a team minded approach to achieve individual and company success.

Able to confidently deal with ambiguous issues and provide input towards suitable actions.

 

Working Relationships:

Internal: Manufacturing, purchasing, warehouse, engineering, R&D, QA, RA.

External: Contract manufacturers, suppliers, laboratories, Notified Body, and other as required