Senior Quality Assurance Engineer

2 weeks ago


Tempe, Arizona, United States West Pharmaceutical Services Full time
Job Summary

West Pharmaceutical Services is seeking a highly skilled Sr. Quality Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring compliance to regulatory and ISO Management standards.

Key Responsibilities
  • Provide support for the validation program for the plant or assigned functional area regarding equipment, processes or procedures used.
  • Ensure compliance to West's validation program.
  • Responsible for compliance to regulatory and ISO Management standards.
  • Provide guidance to system/process stakeholders as to content and format of Validation life cycle documentation.
  • Support Engineering and Operations groups during the process development and Validation phases of customer products' life cycles.
  • Provide required training to support qualification activities.
  • Assume the QA responsibilities for reviewing and approval of validation life cycle documentation (PDD, IOQ/PQ protocols, protocol addendums, summary reports, etc.).
  • Provide guidance during protocol incidents process, including reporting, investigations and approval of resolutions.
  • Keep current with all Industry standard practices and FDA requirements for validation, change control and complaint handling.
  • Monitor Change Control system and provide guidance for proper execution and timely closure of Change Controls and Action items.
  • Understanding and facilitation of Risk documentation to ensure compliance with ISO 14971 and ISO 31000.
  • Ensure compliance with Quality, Business Continuity, Safety and Environmental standards and applicable regulations.
Requirements
  • Bachelor's degree or equivalent experience in a technical discipline including Biology/Microbiology, Chemistry or Engineering.
  • Graduate degree (MS) preferred.
  • Minimum of two (2) years' experience writing, executing and summarizing protocols.
  • Knowledge of FDA, cGMP, ISO and Clean Room standards.
  • Knowledge of validation of automated assembly, software, and manufacturing processes.
  • Knowledge of ANSI/ISO standards.
  • Excellent written and verbal communication skills.
  • Good problem-solving skills and be able to function independently or as a member of a team.
What We Offer

West Pharmaceutical Services offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are an equal opportunities employer and welcome applications from diverse candidates.



  • Tempe, Arizona, United States MillenniumSoft Full time

    Job Title: Senior Quality Assurance EngineerMillenniumSoft is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring the highest quality standards in our medical device products.Key Responsibilities:Lead design and process root cause analysis and support...


  • Tempe, Arizona, United States Actalent Full time

    Job Title: Senior Quality Assurance EngineerActalent is seeking a highly skilled Senior Quality Assurance Engineer to join our team in Tempe, Arizona. As a key member of our Quality team, you will be responsible for ensuring the quality and compliance of process development and manufacturing of implantable electronic products.Responsibilities:Ensure internal...


  • Tempe, Arizona, United States LanceSoft Full time

    Job DescriptionWe are seeking a highly skilled Senior Quality Engineer to join our team at LanceSoft. As a Senior Quality Engineer, you will be responsible for ensuring the quality and compliance of process development and manufacturing of implantable electronic products at our Tempe Campus.Your primary responsibilities will include:Ensuring internal quality...


  • Tempe, Arizona, United States Redbock - an NES Fircroft company Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Engineer to join our team at Redbock - an NES Fircroft company. The successful candidate will be responsible for ensuring the quality and compliance of process development and manufacturing of implantable electronic products at our Tempe Campus.Key ResponsibilitiesDevelop and implement quality...


  • Tempe, Arizona, United States VDart Inc Full time

    Job Title: QA Engineer CoordinatorAbout the Role:We are seeking a highly skilled QA Engineer Coordinator to join our team at VDart Inc. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality of our software applications.Key Responsibilities:Develop and execute manual and automated test cases for software...


  • Tempe, Arizona, United States ALIGN PRECISION - TEMPE, LLC Full time

    Job DescriptionAlign Precision is seeking a highly skilled Quality Assurance Engineer to join our team in Tempe, LLC. As a Quality Assurance Engineer, you will be responsible for ensuring the quality of our products and services by identifying and implementing quality improvement initiatives.Key Responsibilities:Develop and implement quality control plans...


  • Tempe, Arizona, United States West Pharmaceutical Services Full time

    Job SummaryWe are seeking a highly skilled and experienced Quality Assurance Manager to lead our quality assurance strategy across the West, Arizona site. As a key member of the Site Leadership Team, you will oversee the elements of quality operations, quality control, and quality system functions to ensure compliance with regulatory requirements and...


  • Tempe, Arizona, United States TEKsystems Full time

    Job Title: Quality Assurance EngineerWe are seeking a highly skilled Quality Assurance Engineer to join our team at TEKsystems. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality of our hardware and firmware products.Key Responsibilities:Develop and implement testing procedures for hardware and firmware productsPerform...


  • Tempe, Arizona, United States SRP Full time

    About the RoleThe IT Quality Assurance (QA) Analyst will play a crucial role in ensuring the quality delivery of Enterprise Solutions projects at SRP. This position will work closely with application development teams, system integration teams, infrastructure teams, project managers, business users, and other project stakeholders to implement testing...


  • Tempe, Arizona, United States Grove Technical Resources, INC Full time

    Job Title - Sr Quality EngineerJob Location - Tempe, ArizonaDuration: 12 MonthsJob Description - Key Responsibilities:Ensure internal quality processes, procedures, and systems are compliant to all governing standards.Support manufacturing development and continuous improvement as the Quality team member for process development and validation, including...


  • Tempe, Arizona, United States MILLENNIUMSOFT Full time

    Job Title: Quality Assurance SpecialistMillenniumsoft is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Provide quality engineering representation on various project teamsInitiate new or revised...


  • Tempe, Arizona, United States West Pharmaceutical Services Full time

    Job SummaryWest Pharmaceutical Services is seeking a highly experienced and skilled Senior Quality Manager to lead our quality assurance strategy across the Arizona site. As a key member of the Site Leadership Team, you will oversee the elements of quality operations, quality control, and quality system functions to ensure compliance with regulatory...


  • Tempe, Arizona, United States West Pharmaceutical Services Full time

    Job SummaryWest Pharmaceutical Services is seeking a highly skilled Sr. Quality Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring compliance to regulatory and ISO Management standards.Key ResponsibilitiesProvide support for the validation program for the plant or assigned functional area regarding equipment,...


  • Tempe, Arizona, United States MILLENNIUMSOFT Full time

    Job Title: Quality Assurance SpecialistMillenniumsoft is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Provide quality engineering representation on various project teamsInitiate new or revised...


  • Tempe, Arizona, United States INSPYR Solutions Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Engineer to join our team at INSPYR Solutions. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality and reliability of our software applications.Key ResponsibilitiesDevelop and execute manual and automated test cases for software applications to ensure the...


  • Tempe, Arizona, United States Grove Technical Resources, INC Full time

    Job Title: Medical Device Senior Quality EngineerJob Location: Tempe, Arizona (Fully Onsite)Type: W2 contractKey Responsibilities:Ensure compliance to governing standards through internal quality processes, procedures, and systems.Support manufacturing development and continuous improvement as a Quality team member for process development and validation,...


  • Tempe, Arizona, United States AGC Multi Material America, Inc. Full time

    Job DescriptionAGC Multi Material America, Inc. is a leading manufacturer of advanced materials, and we are seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring that our products meet the highest standards of quality and safety.Key Responsibilities:Develop and implement quality...


  • Tempe, Arizona, United States Experis Full time

    Experis Game Solutions Quality Assurance Test Manager Job DescriptionExperis Game Solutions is seeking a highly skilled Quality Assurance Test Manager to join their team. As a QA Test Manager, you will be a key member of the Quality Assurance department, supporting the Microsoft program. The ideal candidate will have strong leadership skills, excellent...


  • Tempe, Arizona, United States L3Harris Full time

    Job Title: Quality Assurance SpecialistJob Description:As a Quality Assurance Specialist at L3Harris, you will play a pivotal role in maintaining product quality and ensuring process integrity. Your analytical skills will be crucial in dissecting complex specifications and executing root cause analyses to implement effective corrective actions.Key...


  • Tempe, Arizona, United States MILLENNIUMSOFT Full time

    Job Title: Quality Assurance AssociateJob Summary:We are seeking a highly motivated and detail-oriented Quality Assurance Associate to join our team at MillenniumSoft. As a Quality Assurance Associate, you will be responsible for ensuring the quality of our products by performing testing and inspection activities in accordance with regulations and...