DIRECT HIRE event for multiple positions at Pall Corporation in Duncan, SC! Benefits and PTO eligibility start day one!
When: Thursday, March 17, 2022 (3 p.m. – 6 p.m.)
Event Location: Pall Corporation, 816 Berry Shoals Road Duncan, SC 29334
Dress code: Dress code is casual (please wear close toe and close heel shoes)
Job Openings & Shifts Available
– Team Manager – Quality Compliance & Release – 1st shift
– Team Manager – Quality Engineering – 1st shift
– Quality Assurance Specialist- Batch Release – 3rd shift
– Manufacturing Engineer – 1st shift
– Department Manager – 1st shift
– Danaher Business System Leader – 1st shift
Shift Hours
– 1st shift (6 a.m. to 2:30 p.m.)
– 3rd shift (10 p.m. to 6:30 a.m.)
Perks of the Job
– Benefits and PTO start day 1
– Unlimited paid-time-off (PTO)
– Paid holidays
– Tuition reimbursement program
– 401K
– Clean environment
– Climate controlled
– Medical insurance
– Vision insurance
– Dental insurance
– Bonus opportunities
Requirements
– Master’s or Bachelor’s degree in applicable field or equivalent by experience in Quality in a similar (GMP)/ISO regulated BU/industry
– 5+ years of quality experience
– At least 3 years of applicable industry experience
– First experience as a manager can be an asset
– Understanding of statistical improvement tools and lean manufacturing techniques
– Language: English (written spoken)
– Strong working knowledge of quality assurance principles and practices, industry and international laws and standards
– You are familiar with ISO9001, some knowledge of ISO 15378/ ISO13485 is an advantage
– Knowledge of ISO11137, ISO14644 and ISO14698 is a plus
– Validation/qualification experience and project management are an asset
Responsibilities
The Team Manager of Quality Compliance & Release provides coaching and direction to the local Quality Compliance Officers and Quality Specialists. He or she oversees the functionality of the Compliance and Release team by providing guidance and instruction and provides support to the Quality Manager. In addition to managing people, the Quality Team Manager will be involved and take the lead in Quality tasks and get involved in larger quality projects within the applicable area.
– Responsible for final product release to market– Main areas of responsibility are divided in approximately 30% customer audits and 50% Quality Systems activities and 20% product Release activities
– Maintain the overview of the certified state of products, processes, methods and equipment. Handle deviations of any kind (NCR)
– Responsible for plant-wide continuous improvement projects
– Lead Customer/Certification audits; Plan and prepare the audit with the customer and local site; Look after customer/certification body during the audit; Agree on action plans together with the process owners
– Communicate action plans as a response to the reported non-conformities; Implement and maintain specified audit plan based, management of associated corrective actions
– Ensure compliance with ISO9001
– Be system administrator in our global document management system (SmartSolve); Review Quality documents; Support in training activities related to SmartTrain
– Complete Customer Quality Systems questionnaires; Maintain QMS in accordance with Corporate and BU requirements
– Prepare and rollout plant-specific training; provide corporate QARA training to plant associates
– Responsible for certification of products; Guide and support Quality Specialist in their activities
– Handling deviations (NCR) and reporting metrics related to NCR; Guide BU QMS implementation on local site; Support implementation of BU QMS improvement action plans
– Implement continuous improvement practices, including appropriate Kaizen events related to QCR
– Prepare input into site management review meetings; Facilitate customer Quality visits and Gemba visits; Develop talent within the QA function
– Manage local product specifications
– Master’s or Bachelor’s degree in applicable field or equivalent by experience in Quality in a similar (GMP)/ISO regulated BU/Industry
– 5+ years of quality experience
– At least 3 years of applicable industry experience
– First experience as a people manager can be an asset
– Understanding of statistical improvement tools and lean manufacturing techniques
– Language: English (written & spoken)
– Strong working knowledge of quality assurance principles and practices, industry and international laws and standards
– You are familiar with ISO9001, some knowledge of ISO 15378/ ISO13485 is an advantage
– Knowledge of ISO11137, ISO14644 and ISO14698 is a plus
Responsibilities
The Quality Team Manager Quality Engineering provides coaching and direction to the local Quality Engineers. Oversees the functionality of the Quality Engineering team by providing guidance and instruction. The Team Manager QE provides support to the Quality Manager. Besides the people management role, the Quality Team Manager will still be involved or take the lead in Quality tasks or get involved in larger quality projects within the applicable area.
– This role will be the lead of the sub-department Quality Engineering
– Will be handling the Site Customer Complaint handling unit. As such will be responsible for final approval of Customer complaint reports, related CAPA and will be leading related customer calls
– You will also be leading a group of quality engineers that ensures validation compliance of our products, processes, methods and equipment by making sure validation documentation and related engineering reports are reviewed and approved
– Main areas of responsibility are divided in approximately 30% customer complaint and CAPA handling and 50% Validation and project activities and – 20% taking care of changes (Management of change MoC) and risk assessments
– Keeping oversight of sustaining projects and their quality documentation package
– Maintain the overview of the validated status through the Master validation plan
– Responsible for handling the applicable sterility claims and irradiation compliance
– The Team Manager QE is the Quality responsible person in plant-wide continuous improvement projects related to Quality engineering
– Handle customer complaints
– Follow up on complaint handling in multi-functional Daily Management
– Review and approve customer complaint investigations and related reports
– Plan, manage & lead for cause audits related to complaints
– Agree on action plans together with the process owners
– Communicate action plans through reports and customer calls
– Follow up on CAPA in multi-functional meetings
– Ensure validation compliance of products, processes, methods and equipment:
– Responsible for keeping an oversight of the validated state in the validation master plan
– Review and approve validation packages (URS, VP, DQ, IQ, OQ, PQ, VR, engineering reports) and their related data analysis
– Provide quality guidance in validation projects
– Explain validated state during customer audits and customer calls
– Handle sterility claim and irradiation compliance
– Responsible for maintaining and detailing sterility claims (master set approach)
– Responsible for dose mappings
– Ensure validated state of irradiation suppliers
– Participate in and guide management of change process (MoC) for all kinds of projects (gated or non gated):
– Be a proactive actor in making certain that all product modifications are investigated where necessary
– Manage resources to have quality representatives in the main plant wide projects providing quality inputs and guidance towards validation, risk assessment, field assessment, documentation compliance, etc.
– Perform Data analysis and implementation of continuous improvement plans to meet agreed KPI’s
– Implement continuous improvement practices, including appropriate kaizen events related to QE
– Prepare input into site management review meetings
– Facilitate customer Quality visits and Gemba visits
– Mentor the professional development of direct reports through personal and performance management
– Promote continuous development and improvement within your team and broader engineering organization
– Enable effective decision making and risk evaluation using quantitative and qualitative quality metrics
Requirements
– Bachelor’s degree in a scientific field, preferably in Life Sciences (Bio, Biomedical, Chemical, Pharma) or related experience
– 1-3 years of experience in a quality and production environment
– Good knowledge of GMP Requirements, including Good Documentation Practices
– Good analytical skills and knowledge of problem solving techniques
– Aware of and appropriately uses DBS tools
– Engaged and supportive of continuous improvement
– Ability to work both independently and with a team in a collaborative setting
– Knowledge of the English and Dutch language (both oral and in writing)
– Familiar with Microsoft Office
– Knowledge of Six Sigma tools and SAP
– Knowledge of quality standards (e.g. ISO 9001 is an asset)
– Excellent organizational skills along with strong attention to detail and time management
Responsibilities
In this role you are part of the Quality Assurance team and responsible for the batch record review and final product release and certification. Another part of the job is related to the maintenance of quality data, creation of sample plans and the support of other routine Quality Assurance tasks.
– Review batch documentation records to ensure goods are being released in compliance with the current specifications and internal procedures in a timely and thorough manner
– Review Certificates of Sterility/Irradiation to ensure that goods are treated according to the validated settings
– Review customer facing documents to assure GMP compliance
– Data analysis and implementation of continuous improvement plans to meet agreed KPI’s
– Certify finished goods for release to customer
– Initiate Supporting activities for GDP and RFT actions
– Reject non conform goods according to current procedure
– Support quality investigations of cGMP products as required
– Perform internal auditing and quality inspections routinely on the shop floor as preventive measure
– Coordinate, maintain and participate in the Kamishibai auditing system at Gemba related to quality aspects
– Identify, investigate and prepare reports on quality issues
– Initiate and follow-up on CAPA’s related to Internal Deviations
– Support in GMP/GDP Training and awareness programs
– Use of day-to-day risk-based approach
– Support customer audits regarding questions related to batch release
– Maintain effective communication and partnership with other departments
Minimum Qualifications
– Bachelor’s degree in Engineering (Mechanical, Manufacturing, or Process Engineering preferred)
– Minimum of 2 years experience in a manufacturing environment
– Understanding of current manufacturing processes and best practices (equipment, robotics, non-conformance procedures, etc.)
– Experience building, updating, and changing manufacturing routings and work instructions
– Proficient in MS Office (Outlook, Excel, Word, PowerPoint)
– Knowledge of production control/ERP Systems
– Experience with lean manufacturing tools and methodologies (Standard Work, SMED, TPM, 5S, etc.)
– Experience identifying and implementing improvements to processes, fixtures, jigs, and tooling
Preferred Qualifications
– Minimum of 5 years of work experience in electronics and machine maintenance
– Experience in a cleanroom environment
– SAP experience (specifically in manufacturing environment)
– Ability to view and manipulate CAD drawings (AutoCAD or other)
– Frequent standing, sitting, bending, twisting, lifting and/or walking for extended periods
– May be required to lift up-to 40 pounds daily
– Ability to work in a cleanroom environment (>50% of the time)
– Gemba biased – likes to see issues on shop floor and be hands on with production associates
– Keen eye for quality – ensuring that products meet specifications, and team is compliant with all policies and procedures
– Understanding of production operations, equipment, and technology
– Ability to identify and implement process improvements under minimal supervision
– Excellent written and verbal communications skills – able to communicate effectively to all levels of the organization (from shop floor associates to plant and operations leadership)
– Ability to research, brainstorm, and implement creative or novel solutions
– Demonstrated leadership of small teams (up to 6 associates) in problem solving/root cause and corrective action development and/or Kaizen events
– Ability to multitask and problem solve
– Excellent attention to detail and organizational skills
– Comfortable handling ambiguity and creating detailed action plans to tackle broad directions or problems
– Excellent attention to detail and organizational skill
– Must be willing to support off-shifts as required (including evenings, nights, and/or weekends) to meet company goals
Responsibilities
Manufacturing Engineers (ME) support the manufacturing associates, equipment, and processes to ensure products meet the required specifications. ME’s are vital to improving the safety of our associates, quality, delivery, and cost of our products through monitoring manufacturing processes and implementing robust solutions. As an ME, you will be responsible for creating and maintaining clear work instructions, routers, and other supporting documentation to ensure every aspect of production (assembly, testing, etc.) is properly completed to meet the product specifications. Successful ME’s enjoy challenging processes, can quickly identify process waste, and break down problems to discover the improvement opportunities. ME’s are also responsible for adhering to the strict regulatory bodies, quality standards, product characteristics and product design integrity.
– Create and maintain all process documents (including routings, procedures, testing processes, standard work, etc.) to ensure manufacturing is performed safely and meets the documented quality specifications– Design and implement fixtures, jigs, and tooling to support production and improve safety, quality and delivery of our products
– Problem solve process breakdowns, equipment malfunctions, and/or product non-conformances – specifically documenting why problem occurred and implementing countermeasures to ensure problem does not reoccur
– Problem solving and dispositioning non-conforming materials (scrap, use-as-is, rework, etc.)
– Identify process improvements to combat excessive process variation/signals, waste, downtime, process deficiencies, operator training gaps, preventative maintenance opportunities, and/or issues to cell design
– Plan, manage, and direct projects, proposals, tests, and evaluations
– Identify, participate in, and lead Kaizen events that drive process improvements – specifically to improve safety, quality, delivery (Lead Time) and cost of manufacturing
– Implement Lean Manufacturing and Statistical Process Control concepts and initiatives– Participates on New Product Introduction Team and is responsible for the transfer of new products from development into production
– Bachelor’s Degree in Engineering, Supply Chain, or Management (Engineering preferred – Chemical, Mechanical, Manufacturing, Industrial or Materials Science)
– Minimum of 3 years of manufacturing supervisory experience including involvement and knowledge of operations, supply chain, planning, receiving, shipping, and material flow
– Minimum of 5 years of experience in a manufacturing environment
– Basic knowledge of accounting and financial practices in an operations/manufacturing environment
– Computer proficiency– MS Office (Outlook, Excel, etc.) & ERP Systems (SAP a plus)
– Experience working in a 24/7 environment (managing 3 shifts)
– Familiarity leading and facilitating lean manufacturing Kaizen events (Daily Management, Value Stream Mapping, SMED, Standard Work, etc.)
– Experience in a regulated environment (ISO, FDA, or otherwise)
Responsibilities
– Own daily management of operational metrics at the Value Stream level
– Drive proactive safety observations and 4E – provide training as required
– Prioritize safety daily – ensuring associates can stay safe while performing daily functions
– Identify and investigate any unsafe situations – with focus on implementing robust countermeasures to reduce or eliminate the risk
– Comply with and monitor 5S in the workplace
– Complete routine audits at cadence to improve team performance
– Confirm quality is evident in daily work – delivering high quality product that meets all customer and quality specifications
– Ensure the team works according to regulatory guidelines – providing coaching to earn and retain ISO and other regulatory certifications
– Identify, coach and implement quality improvements to reduce scrap and improve customer critical to quality metrics
– Accountable for daily schedule meeting rate and On-Time Delivery (OTD) requirements
– Strategically work with planning department and associates to improve efficiencies
– Ensure compliance to First-In First-Out (FIFO) drive inventory turns
– Oversee value stream operations to ensure all inventory is accounted for and following correct processes
– Owns problem solving around headcount vs. output to ensure we can hit delivery schedule while optimizing cost
– Lead (directly or indirectly) the team to implement labor cost reduction projects and process improvements
– Hold team accountable to hourly output expectations, collaborate to ensure downtime is resolved immediately and apply permanent counter measures where applicable
– Ensure bottleneck operations OEE is captured and used to drive improvement
– Owning Daily Management (SQDIP) – ensuring metrics and targets align with business/plant objectives
– Leading Problem-Solving Process (PSP) to understand gaps in value stream (and cell) performance
– Identifying waste and trends from daily management to develop Kaizen charters
– Participating, leading, and facilitating kaizen events
– Supporting and/or leading DBS initiatives, champion projects which increase the overall efficiency of the manufacturing operation
– Seizing the opportunities to train and develop your team in the DBS tools
– Take ownership of driving diversity and inclusion (D&I), including regular meetings around engagement action plans, advocating for associate resource groups, and other initiatives
– Drive the cross-training associates to ensure labor capacities meet required workload and minimize risk of downtime due to skill sets
– Coordinate training schedules and support advancements
– Provide timely mentoring and discipline when required
– Completing time & attendance regularly – ensuring employee time-off and work schedules allows for deliveries to be met
– Hiring and onboarding of new associates – including training when required
– Preparing and delivering yearly performance evaluations (including performance and development goals)
– Leveraging organizational talent assessment (OTA) to access employee potential and to ensure talent pipeline is healthy
– Driving Diversity & Inclusion (D&I) within the organization so every associate feels motivated and comfortable coming into work everyday
– Perform other duties as assigned
– Bachelor’s degree in Business or Engineering required; Master’s degree preferred
– Appropriate practitioner experience in function/area supporting
– Ability to accurately assess key business metrics and situations from a “general manager’s” point of view
– Ability to design, develop, and implement a DBS roadmap for an operating business
– Mastery of a variety of DBS tools (either Lean or Growth related DBS Tools, depending on areas(s) they support)
– Familiarity with various manufacturing process technologies
– Good writing and administrative skills, including computer skills (MS Office, SAP, MiniTab/Quality Analyst preferred)
– Experience with manufacturing planning/scheduling, and lean manufacturing concepts
Responsibilities
Drive targeted, balanced improvement in SQDC (Safety, Quality, Delivery, Cost) that is tied to Policy Deployment (PD) and Daily Management (DM) by using DBS tools, consulting skills, and the change management process. Drive site/company Leadership in the development of a DBS Roadmap (i.e., how to use the DBS tools to drive sustainable improvement in results). Directly provide formal and informal DBS training and coaching. Be an active Leader in PD and Daily Management reviews (as appropriate). Help Danaher continue the evolution of the DBS tools (main contact here is DBS Office or DBSO). Ensure successful kaizen events by installing and ensuring compliance to the kaizen process (includes):
– Planning of Kaizens with a dynamic funnel process tied to PD and Daily Management; Kaizen execution and sustainment of Kaizens, engaging team throughout process
– Lead diagnosis of work flow impediments and other wastes throughout the business, and provide experienced counsel on appropriate DBS (Lean/6 Sigma) tools to eliminate them
– Lead/facilitate root cause analysis (problem solving) using DIVE/DMAIC process – develop team members through process
– Improve DBS training and facilitation skills by pursuing certification in DBS tools
– Lead associate development in various DBS tools and kaizen leadership
– Benchmark and incorporate standard methodologies from other Danaher locations
– Utilize Statistical Process Control (SPC) to define problems and analyze data
– Manage strategic projects from conception through sustainment, facilitate execution of action plans
Job Location: Pall Corporation – 816 Berry Shoals Road Duncan, SC 29334
HTI and Pall Corporation are Equal Opportunity Employers M/D/F/V/SO
