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West Pharma Senior Quality Engineer 
United States, North Carolina 
681079419

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Essential Duties and Responsibilities
  • Coordination of product transfers between West plants including documentation, coordination of trials and round robin studies, root cause analysis in case of differences detected.
  • Initiating, Leading/ Supporting projects (Quality improvement, automation, and R+D projects) using established project management tools.
  • QA support for plant and global projects including technical consultancy with respect to approach, structure and implementation strategies
  • Support and Management of risk analysis and initiation of risk mitigation and corrective actions.
  • Data collection, evaluation and trending of quality-relevant measurements.
  • Creation of annual product reviews including data analysis and CAPA management
  • Support of internal and external project such as improvement projects, automations, and transfer from a quality point of view.
  • 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.
  • Responsible 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.
  • 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.
  • Other duties as assigned.
Education
  • Bachelor's Degree in Engineering or Science or equivalent experience required
Work Experience
  • 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
Preferred Knowledge, Skills and Abilities
  • 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
  • Must be able to pass color vision and visual acuity test to 20/30 with corrected or uncorrected vision
  • Able to comply with the company’s safety and quality policies at all times
License and Certifications
  • 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
Additional Requirements
  • 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.
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

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