Quality Engineer Exton Pennsylvania West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2017 sales of $1.6 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world. Job Summary: In this role, you will liaise with customers and suppliers on new and existing metrology / quality projects. Plan, schedule, execute & communicate all items regarding metrology and quality issues / programs to direct Manager and/or other interested parties. Contribute or lead workstreams allocated to Quality or dimensional measurement system development for customer focused initiatives associated with new product development or optimization of existing product. Participate in steering committees which originate from both corporate and manufacturing facilities. Conduct data trend analysis to identify short and long-range patterns so that recommendations can be made to effect continuous improvement necessary to satisfy customer requirements. Support quality assurance improvement activities by evaluating products, processes or materials to develop control or improvement strategies intended to improve the customer s experience. Support the training of local metrology operators, ongoing re-fresher training and assessment to determine level of competency on a frequent basis. Essential Duties and Responsibilities: Lead the identification, and development of innovative solutions to measure dimensional attributes on West product and aligned to West or / customer drawings. Work independently and with project teams to develop design control deliverables including quality plans, manufacturing & inspection documentation, test methods, and any necessary records for compiling design history file. Liaise with customers and suppliers on new and existing metrology / quality projects. Chairing customer meetings reviewing measurement systems, data analysis and inspection reports. Contribute or lead workstreams allocated to Quality or dimensional measurement system development for customer focused initiatives associated with new product development or optimization of existing product. Participate in the development and maintenance of product risk and hazard analysis in accordance with ISO 14971. 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 management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence of targeted defect or failure mode. Conduct data trend analysis to identify short and long-range patterns so that recommendations can be made to effect continuous improvement necessary to satisfy customer requirements Design and perform DOE s (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols. Support the training of local metrology operators, ongoing re-fresher training and assessment to determine level of competency on a frequent basis. Meet company and departmental goals in the continuous improvement of all products, services and processes. Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules. Support to operations, development and quality departments. Provide quality reports and review trending on assigned areas of responsibility to help identify areas of improvements. Drives a culture of continuous improvement and lean operations. Performs other duties as assigned based on business needs. Other duties as assigned Basic Qualifications: BS degree preferably in a technical discipline such as Engineering, Chemistry, Physics, or Materials Science Minimum 3-5 Years of related work experience Computer skills (especially MS Office applications & statistical analysis systems) General understanding of manufacturing and plant operations Preferred Knowledge, Skills and Abilities: Knowledge of ISO/ASME GD&T requirements, interpreting 2D engineering drawings and 3D models Proven experience of Measurement System Analysis (MSA) development, Minitab and statistical packages is essential. Strong problem solving and critical thinking skills to troubleshoot issues and identify root causes. Experience using Six Sigma & SPC tools and techniques Experience with ISO 9000 standards and GMP s a must ASQ certification highly desired. Green Belt certification a plus. Graduate degree (MS) a plus. Planning/organizational skills Negotiation skills Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description Travel Requirements: Must be able to travel up to 30% of the time Physical & Mental Requirements: Use written and oral communication skills Must maintain the ability to work well with others in a variety of situations. Ability to make independent and sound judgments. Read and interpret data, information and documents Analyze and solve problems Use complex arithmetic reasoning West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a disability or special need that requires accommodation, please send an email to ...@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening. Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.