דרושים Quality Engineering Team Leader ב-West Pharma

In this role, you will be responsible to handle raw materials acceptance activities, NCM reports related to raw materials, write and update procedures and forms related to incoming inspection.

• Responsible for raw materials acceptance activities in ERP/SAP, including approval of acceptance records generated by incoming inspectors and issuance of Certificate of Compliance for approved raw material.
• Responsible to verify that all acceptance test results follow GMP and GDP guidelines
• Responsible for handling of all related incoming inspection non-conforming materials (NCM), including performing root cause analysis, generate corrective actions and leading MRB meetings to determine the materials disposition.
• Responsible to write Special inspection /Rework instruction related to incoming inspection process
• Responsible to write and update incoming inspection Forms and procedures
• Responsible for the approval of all graphic and label related raw material.
• Responsible for the approval of Line clearance performed by quality inspectors

• Education- Technical/ Practical Eng.
• At least 2 years of relevant experience in Quality in the Medical Device/pharma industry
• Courses related to Medical Device regulation- an advantage
• Knowledge with ERP/ SAP- an advantage

• At least 2 years of relevant experience in Quality in the Medical Device/pharma industry

• Ability to work under pressure
• Good interrelation skills
• Technical ability- ability to read technical drawings
• Creativity
• High Learning ability
• Organized
• Ability to prioritize
• Excel -basic knowledge and experience.
• Written and verbal communication skills: Hebrew- Mother tongue . English- Good

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
• Must maintain the ability to work well with others in a variety of situations
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
• Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.
• Effectively communicate and interface with various levels internally and with customers

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.

• Exhibit a strong “quality first” mentality and ensure that product and quality are held to the highest standard.
• Meet company and departmental goals in the continuous improvement of all products, services and processes.
• 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 QA procedures and VoE.
• Supports special processes such as sorting or rework in production.
• Own on 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 relates 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 which 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.

B.Sc. in Science or Engineering

• 3years of experience in Medical Device Quality & Productionifecycle
• Relevant work history and/or experience may be considered in lieu of degree
• Experience with production processes and process controls
• Experience with sub contractors interface and meeting customer expectations
• Experience with Medical Device, Validation Activities, Risk Management, Product Transferto production
• Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP
• Must have effective problem solving and interpersonal skills
• Ability to work independently, multi-task and thrive in fast-paced environment
• Problem solving including root cause failure analysis methods

• Previous experience with MasterControl, Share Point, Teamcenter- a plus
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations
• Maintain high attention to detail, accuracy, and overall quality of work
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Observe and interpret situations, analyze and solve problems
• Effectively communicate and interface with various levels internally and with customers
• Certified auditor- a plus
• Relevant work history and/or experience may be considered in lieu of degree

• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve and prioritize.
• Self-motivated with the ability to make independent and sound judgments.
• Read and interpret data, information, and documents
• Learn and apply new information or skills

• Contribute to the development and implementation of quality management programs focusing on continual improvement across various processes.
• Create processes to better evaluate, track and trend audit outputs and identify risks/issues and evaluate impact on global quality systems and initiate actions, as needed.
• Coordinate communication between internal teams.
• Regularly analyze data trends, drive improvements and meet customer expectations through efficient reporting and communication.
• Reviews, revises, and creates operating procedures to ensure compliance with all related external requirements, internal procedures or instructions, and the West Quality Manual.
• Ability to lead meetings with relevant teams, employees and contractors as necessary to manage changes.
• Establishes monthly KPI’s and metrics to Quality Leadership.
• Drive continuous quality improvement projects across the enterprise for increased compliance and to create efficient use of company resources.
• Leading personnel responsible for calibration activities monitoring, calibration reports approvals. Responsible for calibration specifications approval and for reviewing and approving calibration deviations.
• Lead the site’s device sterilization methods establishment, validation, maintenance and routine controls as the site sterilization SME by verifying that the sterilization methods validation is done according to the applicable standards and regulations. Verify the sterilization methods and risk-based approach are routinely maintained. Address sterilization issues and provide solutions to sterilization challenges. Be a part of the West Global Sterilization Council and provide support to other West CM and Medical device sites with Sterilization issues. Be key focal point with the West IL sterilization service providers related to sterilization matters.
• Independently performs supplier audits and corporate facility audits

• Data Reviewer: - Review and approve laboratory procedures, work instructions, ESOPs, EWIs, PFNBs, protocols, forms, method transfers, reports, analyst analytical training, etc. - Review all WSS documentation for compliance to West and/or Client policies and procedures, cGMPs and applicable ISO standards.Investigations: - Liaise and collaborate with the WSS departments/clients to initiate, investigate, review and approve OOS investigations and reports and any other lab investigations as deemed necessary. - Conduct root cause analysis and issue appropriate corrective action when deemed necessary. - Work/interface with Lab personnel for continuous improvements related to CAPA and/or customer or regulatory requirements.Audits: - Plan, host and co-ordinate Customer, ISO, Corporate QA, and Regulatory audits/inspections of WSS facilities. - Coordinate the responses to customer audit observations, customer complaints and request for information/documentation. - Assure execution of internal quality audits, according to established procedures for the assigned areas / locations. - Provide response to audit observations, and customer complaints and inquiries.

• Bachelor's Degree In Engineering or Science required and
• Master's Degree In Engineering or Science preferred

• Minimum 5 years Experience in regulated Quality Assurance / Document/Configuration Control (or a formal education equivalent) required and
• Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities preferred and
• Experience with quality systems such as ISO 9001, ISO 15378 and ISO 13485, 21 CFR 820 preferred and
• Experience Leading Internal / External Audits, MasterControl, SAP and Share Point preferred and
• Experience with customer interface and meeting customer expectations preferred

• Ability to work independently, multi-task and thrive in fast-paced environment.
• Excellent written and verbal communication skills
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Proven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485.
• Familiarity with root cause analysis tools
• Working knowledge of MasterControl and SAP
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual
• Able to comply with the company’s safety policy at all times.

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual
• Approval of calibration certificates and deviations
• Reviewing and Approval of Bioburden and dose audit reports.

• Identify project requirements
• Drive completion of project milestones, as determined by the team, based on timelines and project goals through all stages of the project
• Actively support project initiatives
• Ensure requirements for projects are achieved
• Ensure that all required documentation deliverables are satisfied and delivered
• Lead projects with moderate resource requirements, risk, and/or complexity to achieve milestones and objectives.
• Solves complex problems by taking a new perspective using existing solutions.
• Drives transparency of project workloads, financial, commitments, and expectations. Maintain the project related data within the West Project Management System.
• Monitor resource needs and issues, work closely with resource managers to develop action plans to ensure project commitments remain on track.
• Manage project dependencies, escalating to the functional PMO as needed.
• Ensure projects are planned properly, including financials, resourcing, scheduling, and the business case, in support of quality deliverables. Analyze, Forecast and Report the project budget.
• Define, drive and manage change management and communications activities that support assigned projects.
• Champion of the functional process and methodologies as applicable to projects/project teams.
• Executes on departmental strategy.
• Performs other duties as assigned based on business needs.

• Works independently with minimal guidance.
• Develops technical knowledge, requires working knowledge and experience in project management.
• Manages single workstreams locally/globally and may work across multiple workstreams.
• Maintain clear communication paths with stakeholders.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.

• Bachelor's Degree Science related field, Chemistry, Biology, engineering required

• Minimum 8 years required