דרושים Quality Engineering Manager ב-West Pharma ב-United States, Tempe

Responsible for maintaining operation efficiency of automated assembly lines. Provide support to shift operations as request by the shift leader/production manager. Develop long-term predictive/preventative maintenance plans for all assembly equipment.

• Logically troubleshoots and repairs the pilot assembly line and related bench top equipment.
• Assists shift lead in maintaining quality of finished product through proper machine operation.
• Responsible for maintaining spare parts inventory with a proper cataloging of parts.
• Provide a timely notification to shift lead of maintenance issues and downtime.
• Reviews line history and documentation to enhance line efficiencies. Follows escalation plan to minimize downtime.
• Maintains and updates all equipment log books with accurate repair/adjustment information.
• Interfaces daily with shift leader and technician at shift change.
• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly and safe workstation and environment at all times.

• Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Performs other duties as assigned based on business needs.

• High School Diploma or GED Required

• 1 year experince with troublshooting manufacturing machinary.

• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments. May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.

• Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project planning. Proactively identify gaps and risks to project success and implement mitigation strategies to minimize impact.
• Collaborate with cross-functional teams, internal and external to the laboratory, to coordinate project execution and ensure that project objectives and success criteria are met.
• Provide Quality Engineering direction to multiple concurrent product development programs to ensure product and process compliance to all applicable regulatory and cGMP requirements, including ensuring all relevant safety procedures are employed.
• Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification and validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing records, etc.)
• Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures and ISO standards.
• Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control, change controls, configuration management, etc. Provide direction on any nonconformance, deviation, or excursion that may occur and drive to closure. Author and review product development QMS procedures and work instructions.
• Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
• May work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any other necessary quality records. Provide quality reports and review trending on assigned areas of responsibility.
• May support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
• May assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process Statistical Process Control programs.
• May perform DOEs (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols, and identify and remedy equipment and/or process documentation gaps and provide appropriate training where needed.
• May have people management responsibilities.
• Other duties as assigned.

• Bachelor's Degree in Engineering or Science or equivalent experience required

• Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities required and
• Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success required and
• In-depth knowledge of cGMP regulations, ISO 17025, ISO 11040, ISO 13485, 21 CFR 820, ISO 14971 required and
• Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities, and proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point required and

• Experience with MasterControl, SAP, Share Point, Teamcenter
• Experience with ISO 11040, ISO 11607
• Expertise in quality management tools. Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc
• Strong working knowledge of quality systems of the respective ISO norms
• Working knowledge of supplier quality management from product development to mass production.
• Strong project management skills
• Proficient in computer system applications (SAP, master controls, etc) communication skills
• Excellent critical reading and writing skills
• Problem solving including root cause failure analysis methods
• Be aware of all relevant SOPs as per Company policy as they relate to this role
• Able to comply with the company’s safety and quality policies at all times

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• 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.
• Critical reading skills and 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.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze and solve problems.

• Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred
• Quality\Certified Quality Technician-ASQ (CQE or CQA) Upon Hire preferred
• SO 17025 Auditor or Lead Auditor Training / Certification Upon Hire preferred

Management and implementation of facility projects and support in holistic building management. Perform a wide variety of mechanical, as well as pneumatic maintenance activities and some basic electrical activities on various pieces of equipment to maintain safe operations of equipment while maintaining production goals and quality standards. Other responsibilities include sourcing parts for obsolete parts and ordering them, documenting all the maintenance activities performed, PM's, installation, and validations of equipment. Will support and help other groups like Process Engineering, QA, and Facilities in resolving problems, improvements, investigations etc. In this role you will service/maintain several machines, while learning the others in the department. Work from prints, sketches, sample parts, verbal or written instructions. Interpret drawings, select material plan, and layout work in proper operational sequence. Maintain and setup vision systems during production.

• Identify problems by reading schematics/prints, where available, and make necessary repairs on the equipment or system to ensure safe operation of the machine or system.
• Respond to production maintenance request and any unscheduled down time.
• Troubleshoot and adjust or repair ancillary equipment like blow overs, bulb pullers, and heaters.
• Changeovers and setups on Vision Systems, make minor adjustments as required.
• Perform ink mixing as well as disposing of procedure as per set Safety/QS guidelines for printing machines.
• Perform necessary oil changes on machine gear boxes and dispose of used oil per established procedure.
• Rebuild/retrofit machine or machine components as per specifications.
• Perform installation, replacement or decommissioning of equipment.
• Perform validations as necessary for equipment.
• Work with training department to train new mechanics on machine repair, setup and related plant procedures.
• Complete PM's on or before the due date and communicate to proper authority of job completion.
• Source obsolete parts for equipment and make them stock item.
• Identify and locate parts in the stock room through MP2 or other such system.
• Participate in various company run programs like Continuous Improvement, Safety initiatives, audits, investigations etc.
• Support projects and improvement initiatives from engineering, process, QA, Safety and Operations groups.
• Document performed tasks for the day into the maintenance log before the end of each shift.
• Safeguard all corporate or plant confidential information.
• Use good housekeeping practices to maintain safe, (safe is always first) clean, orderly work area.
• Upgrade technical skills by various educational workshops, on-site or off-site trainings supported by WEST.
• Follow engineering department guidelines and procedures.
• Conforms with and abides by all safety rules, regulations, policies, work procedures and all instructions.
• Exhibits regular, reliable, punctual and predictable attendance.
• Implementation and collaboration of facility projects

• High School Diploma Or GED required

• 3 years manufacturing maintenance experience

• Experience with plastic injection molding preferred.
• Experience with robots and pick in place robots.
• Experience with ISO 9000 standards and GMP’s.
• Excellent communication and interpersonal skills.
• Experience with SAP or similar software for maintenance tracking.
• Agile working style.
• Ability to work weekends and overtime as required

• Mentor and may lead engineering team to achieve site and department goals in a fast-paced environment.
• Collaborate with cross-functional teams to develop and implement sustainable manufacturing processes and systems.
• Technical and hands-on automated equipment troubleshooting, repair, and improvements.
• Perform and document engineering studies and evaluations.
• Analyze data to drive improvements, determine prioritization, and identify opportunities.
• Lead and provide mentorship in root cause and corrective action (RCCA).
• Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
• Champion high-visibility projects. Develop project scope, timeline, savings, and cost estimations.
• Quote new automation lines, engineering services, etc. Develop design concepts for new automation.
• Write validation, user requirements, equipment specification, and other documents as needed.
• Establishes relationships with customer and automation suppliers in pursuit of win?win results and ongoing business.
• Provide engineering assistance to assure plant, machinery, and processes are at an optimum level.
• Routinely evaluate and review employee performance.
• Promote and support a Lean Manufacturing environment within the facility.
• Research new technologies and methodologies to use in the plant.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Perform other duties as assigned based on business needs.
• Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Other duties as assigned.

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

• Minimum 5 years 5-8 years of experience required and
• 2+ years of managerial or supervisory experience in manufacturing environment required and
• Strong automation background and experience with CAD and SAP systems a plus. preferred

• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.

• Manufacturing\Six Sigma Green Belt Certification Six Sigma green belt Upon Hire preferred or
• Manufacturing\Lean Six Sigma Black Belt Six Sigma black belt Upon Hire preferred

• Must be able to perform job duties as required with limited physical demands.

• Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans, utilizing both visual means as well as calibrated test equipment to include laser micrometer, optical comparator and other equipment as applicable
• Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site
• Understand and follow applicable ISO standards requirements
• Perform review of inspection records to assure product conforms to specifications and proper documentation practices
• Retains sample of finished products and maintains all applicable documents to form batch records and ensures appropriate batch records disposition (i.e. filing, scanning etc.) as necessary
• Print documents from Master Control, shopfloor or other software program and manages documents related to the Quality System
• Segregate nonconforming product and handle quarantined product and raw materials as applicable by site
• Generate rejection and deviation reports as directed by site
• Perform trace back investigation of nonconforming raw material and product as directed by site
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules
• Exhibits regular, reliable, punctual and predictable attendance
• Other duties as assigned

• High School Diploma or GED Required

• Minimum one year manufacturing experience required

• Must poses an acute attention to detail
• Basic computer skills

In this role, you will monitor and control the daily activities of quality inspection, testing, documentation review, and calibration in support of Operations and product release. This role is on-site (Monday through Friday) from 10:00 pm to 6:00 am.

• Able to train, provide trouble shooting guidance/feedback, and problem resolutions on metrology equipment including but not limited to CMM’s (Coordinate Measurement Machine), Vision Systems, and manual gaging.
• Proactively analyze data and interpret results for any trending or OOS (out of specification) events.
• Provides direct supervision, resolves personnel issues, conducts performance evaluations and performs supervisory discipline as necessary.
• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
• Schedule and prioritize quality inspection, testing, documentation review, and calibration to support Operations and release of product.
• Identifies and develops opportunities to improve existing processes and procedures.
• Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
• Assist in and manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished. Advise on equipment condition, test method, etc. to aid in the course of action when components do not meet specifications. Responsible for quality inspection and verification.
• Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non‐Conformance Report is required.
• Assist in developing documentation and procedures during the qualification of new equipment/inspection methods.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance .

Education or Equivalent Experience: Associate’s Degree in Technical or Engineering

• 5+ years experience in regulated Quality Assurance and or metrology and Document/Configuration Control (or a formal education equivalent) required.
• Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Metrology/Manufacturing background and Risk Management preferred.
• Experience with quality systems such as ISO 13485 and 21 CFR 820 preferred.
• Experience with MasterControl, SAP, and SharePoint preferred.
• Experience with customer interface and meeting customer expectations preferred.
• 3+ years of supervisor experience 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 PowerPoint.
• 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.

• Strategically develop production plans in coordination with the Regional Planner/s and direct plant personnel in the execution of the approved plans --- following their review and approval at the monthly Sales and Operations Planning (S&OP) meeting.
• Directs the teams that develop and executes production, inventory, and material plans.
• Adheres to monthly S&OP schedule in providing inputs & managing outputs and participates in all required production and supply chain/customer meetings.
• Collaborates with the regional planner & demand analyst to understand customer demand (inter-company included) and market drivers to facilitate a balancing of capacity (tool, machine and labor), inventory and delivery lead-time in the development of the production plan.
• Partners with the regional planner to aggregate the plant Master Production Schedule (MPS), incorporate forecast & market demand and develop a production plan (VOLUME).
• Implements and oversees vendor managed inventory (VMI) programs.
• Executes Rough Cut Capacity Planning (RCCP) for key resources (tools, machine, labor and material) to establish that the Production Plan is achievable and to recommend the need for additional resources.
• Works with the strategic supply planner to develop and maintain a program to manage raw material sourcing routine for an optimal balance between inventory, cash flow and transportation cost.
• Provides strategic direction and guidance in planning for conversations related to purchasing of raw materials.
• Manages the customer order cycle and communication between plants, headquarters and the customer.
• Monitors manufacturing lead times and delivery performance to assure targeted customer service levels are being achieved.
• Provides oversight and strategic leadership on slow moving and obsolete inventory.
• In the absence of packaged solutions, develops and implements PC/Microsoft based tools.
• Leads effective product transfer plans and supports database coordinator to ensure the integrity and accuracy of the ERP and MES data.
• Develops and manages the training, growth, development, and succession planning for the Supply Chain Department
• Support and contribute to Lean/Six Sigma programs and activities
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Performs other duties, as assigned based on business needs.

• Bachelor's Degree Supply Chain, Engineering, Finance, or Business required
• Master's Degree MBA preferred

Minimum 10 years (Sr Mgr)experience in operational management in the medical device/pharma/plastics injection industry,Prior manufacturing experience in an industrial /cGMP setting andExperience in lean manufacturing systems and costs savings programs which affect company financial and growth plans are Required.

• Manufacturing\Certified in Logistics, Transportation, and Distribution (CLTD)-APICS preferred
• Manufacturing\Certified in Production and Inventory Management (CPIM)-APICS preferred

• Able to sit and/or stand for extended periods
• Able to be able to lift and carry various items up to 40 pounds
• Able to climb stairs and ladders
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Must also be able to maintain confidentiality and resolve conflicts.
• Ability to make independent and sound judgments.
• Read and interpret data, information, and documents
• Analyze and solve problems and interpret situations
• Work under deadlines with constant interruptions