לוח משרות דרושים בשלומי

In this fully onsite role, the Manufacturing Quality Engineer will own all qualiy activities at one of the manufacturing sub-contractors, support the validation process to the contract manufacturing and provide quality oversight to the engineering department, while working within a multi-functional team environment for medical devices. The Manufacturing Quality Engineer will lead projects and tasks, from product validation through transfer to the production and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria. Additionally, this role will identify and implement improvements to the production processes. The Manufacturing Quality Engineer will be the products and production focal point for our sub-contractors and will be responsible for projects related to the production and machines, including training, audits, stop and renew the production.

Essential Duties and Responsibilities
Exhibit a strong quality first mentality and ensure that product and quality are held to the highest standard.
Work cross-functionally with individuals or extended teams to provide guidance and ensure success of projects.
Responsible to write, review and approve pilot documents (including reports).
Write and approve various department and production procedures and forms.
Lead investigation processes for deviations and nonconformities in production and create analysis reports.
Responsible to train the sub-contractors according to QA procedures and VoE.
Support special processes such as sorting or rework in production.
Own all production activities at one of the subcontractors to ensure manufacturing is held according to West procedures and GMP/GDP standards
Responsible for stopping and renewing production with accordance to West requirements and with MQ manager approval.
Manage production related projects and act as MQ focal point in various internal and external projects- such as Data Integrity, CoPQ, production improvement plans, etc.
Provide Quality oversight of validation activities and processes.
Lead pilot processes that include change and approval of quality aspects in pilot protocols and reports and assure that pilot processes are conducted according to West guidance and protocols.
Attend production pilot meetings as the MQ focal point.

This role is located in Shlomi, Israel and must live close to the site to be considered. This role is a hybrid model (3 days on-site/2 remote) However, during onboarding and when required, will need to be onsite.





This fully onsite role will assist in the application of manufacturing systems as well as maintain current systems in the manufacturing process to improve process control and finished goods quality while maintaining high standards of quality and safety on all phases. Provide technical assistance to the manufacturing engineering team, Quality, Global, and production as needed.

Essential Duties and Responsibilities
Ability to specify, test and design machine systems and components, including the ability to write and revise software configurations.
Support lean manufacturing initiatives, identifying reduction opportunities through process improvements, tuning of configurations, or other strategies. Improve the speed and reliability of vision system change-overs.
Responsibility for engineering projects as assigned, allowing the achievement of maximizing output and / or minimizing cost by either the implementation of new equipment and / or methods or the improvement of existing equipment and / or methods.
Plan, schedule, and perform sub-project details; follow-up on new and revised improvements to assure proper implementation.
Support and operate as needed within approved time schedules and project budgets.
Assist coordination of testing new systems before release to production.
Consult and cooperate with corporate / customer / supplier personnel as authorized and required. Maintain effective communication and working relations.
Keep team advised of any unusual situation, which might require additional attention from the project group so that they may act accordingly.
Assist newly trained West Pharmaceutical Services personnel in the use of any special equipment required for project completion.
Provide engineering guidance to assure plant, machinery, and processes are optimized.
Aid in electrical, electronic, mechanical, pneumatic, and hydraulic design modifications.
Help define projects via specifications or drawings before releasing to a vendor.

In this internship role, you will be involved in engineering activities such as issuing technical documentation, supporting equipment validation, production floor supporting and more.

Essential Duties and Responsibilities
Tech Office activities such as Documentations and Drawings.
Supporting Tooling and production processes enhancements (Automation, Jigs and Fixtures- design and built).
Supporting West IL engineers with Equipment and processes qualifications including, documentation, validation support on site, coordinate activities with subcontractors and additional tasks as assigned.
Sustain engineering support for production processes (Machines Maintenance, repairs, spare- parts and enhancements).
Additional Responsibilities
Follow Lean problem-solving techniques.
Some flexibility in schedule is required as needed for new facilities / equipment installation.
Other duties as requested and/or assigned to support the Manufacturing Engineering department.

In this onsite role, the Team Leader Quality Operations leads a team of Quality Engineers that support manufacturing processes and projects, as well as provide quality oversight to the Engineering department within a multi-functional team environment for medical devices. This Team Leader will lead QEs, projects and tasks, from product inception through commercial product and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all applicable regulatory requirements. Additionally, this role will identify and implement improvements within the Quality Management System. The Senior Quality Engineer will be a strong advocate for product, process, and system quality at all stages of manufacturing processes.

Essential Duties and Responsibilities
Exhibit a strong quality first mentality and ensure that products, processes and quality are held to the highest standard, adhere to all company policies, KPIs and follow all safety rules and safety procedures
Lead QEs daily activities, provide support, guidance, set objectives, monitor performance, and follow-ups as required.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
Responsible to provide support to manufacturing related processes, such as (but not limited to) approval of equipment qualification, process risk management and pFMEA, and process validation documents (URS, IQ, OQ, PQ, etc.), and responsible to review, and approve product development DHF documentation (product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, OOSs, product transfer to operations, etc.) in relation to medical devices.
Lead the Quality involvement in development and maintenance of product and hazard analysis in accordance with West policies and procedures.
Provide Quality oversight of qualification/validation/review and approval of documentation and reports/design controls activities to other QEs
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects.
Responsible to review and approve process development QMS procedures and work instructions and support QMS activities as required.
Liaison with company and customers on Quality matters related to engineering projects.
Support routine sterilization validation monitoring activities.