CAPA Process Lead

7 days ago


Pittsburgh, Pennsylvania, United States Integrated Resources Full time
CAPA Process Lead Job Description

Integrated Resources is seeking a highly skilled CAPA Process Lead to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the highest level of quality in our products and processes.

Key Responsibilities:

  • Critically review product and process Corrective and Preventive Actions (CAPAs) in various stages of the CAPA workflow
  • Facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring
  • Support updating the business processes relating to CAPA
  • Perform timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving
  • Project manage all aspects of CAPA activity which includes Producting the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines
  • Support and prepare spokespersons in representing CAPAs during audits and CAPA Review Board meetings
  • Lead and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques
  • Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances
  • Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available
  • Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement

Requirements:

  • Bachelor's degree in an engineering or scientific-related field or other plus equivalent technical experience working in a medical device environment
  • At least 10 year's practical experience with CAPA
  • Able to understand and analyze complex problems, including software and hardware design issues
  • Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations
  • Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971
  • Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels
  • Strong Project Management skills, including ability to project manage all CAPA activities
  • Strong reasoning and logical thinking skills
  • Excellent written and verbal communication skills in English

Estimated Salary: $130,000 - $160,000 per year, depending on experience



  • Pittsburgh, Pennsylvania, United States Integrated Resources Full time

    About the RoleWe are seeking a highly skilled Quality Systems Engineer to join our team at Integrated Resources. As a key member of our quality assurance department, you will be responsible for ensuring the highest level of quality in our products and processes.Key Responsibilities:Critically review product and process Corrective and Preventive Actions...


  • Pittsburgh, Pennsylvania, United States APN Software Services Inc Full time

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at APN Software Services Inc. This is a full-time position based in Bakery Square, with the opportunity to work from home and potentially relocate to Murrysville, PA in the future.Job SummaryThis role will involve working as a subject matter expert on...


  • Pittsburgh, Pennsylvania, United States EssilorLuxottica Full time

    Job Title:Production Process Improvement LeadAbout the Role:We are seeking a skilled Production Process Improvement Lead to join our team at EssilorLuxottica. As a key member of our operations team, you will play a crucial role in evaluating work processes to determine strategies and programs that provide greater productivity and efficiency.Key...


  • Pittsburgh, Pennsylvania, United States Maintec Technologies Full time

    Job SummaryWe are looking for a highly motivated and experienced Manufacturing Process Optimization Lead to join our team at Maintec Technologies in Pittsburgh, PA. As a Manufacturing Process Optimization Lead, you will be responsible for implementing and improving Lean manufacturing tools in projects executed by Services, as well as developing continuous...


  • Pittsburgh, Pennsylvania, United States Carmeuse Americas Full time

    About the RoleWe are seeking a talented Engineering Process Improvement Manager to lead our process optimization initiatives. In this role, you will be responsible for driving business growth through innovation and continuous process improvement.You will work closely with operations, engineering, and project management teams to identify areas for improvement...

  • Hadoop Lead

    7 days ago


    Pittsburgh, Pennsylvania, United States Diverse Lynx Full time

    Diverse Lynx LLC is an Equal Employment Opportunity employer. We promote and support a diverse workforce across all levels in the company.We are seeking a highly skilled Hadoop Lead - Data Processing Expert to join our team.The ideal candidate will have a strong background in Hadoop ecosystem technologies, including PySpark, Hive, and Livy. They will also...


  • Pittsburgh, Pennsylvania, United States Allcor Full time

    Job OverviewWe are seeking a highly experienced Senior Process/Mechanical Engineer to lead our engineering team at Allcor in South Carolina.This role involves designing, planning, and coordinating multi-disciplinary engineering projects through all phases, from concept to construction. Your expertise in mechanical systems and process engineering will...


  • Pittsburgh, Pennsylvania, United States Carmeuse Americas Full time

    Job OverviewCarmeuse Americas is seeking a highly skilled Process Optimization Lead - Stone Production to join our team. This role is responsible for driving business growth through innovation and continuous process improvement.As the preferred contact with Plants, you will assess performance and operations in all limestone processing circuits. You will...


  • Pittsburgh, Pennsylvania, United States BGS US Full time

    About the RoleBGS US is a leading services provider of beta rays for radiation sterilization. We are seeking an experienced Radiation Process Specialist to join our team at our production facility in Imperial, PA.This is a full-time position with competitive pay commensurate with experience. Estimated salary range: $85,000 - $110,000 per year, depending on...


  • Pittsburgh, Pennsylvania, United States Carmeuse Americas Full time

    About the JobCarmeuse Americas is seeking a highly skilled Mechanical Engineer to lead our process engineering efforts. As a key member of our team, you will be responsible for designing, implementing, and maintaining mechanical systems in our lime production facilities.Key Responsibilities:Design and develop mechanical systems, including pumps, fans, and...


  • Pittsburgh, Pennsylvania, United States BGS US Full time

    BGS US, a leading services provider of beta rays for radiation sterilization, is seeking an experienced professional to staff our US-based operations with immediate opportunity at our new production facility in Imperial, PA. The successful candidate will play a vital role in the startup of our high-volume production operations, working closely with our...


  • Pittsburgh, Pennsylvania, United States MSCCN Full time

    About MSCCN: As a leading staffing firm, MSCCN provides top-notch talent solutions to businesses across various industries.Job Requirements: To succeed in this role, you must have a strong understanding of data entry procedures, excellent communication skills, and proficiency in Microsoft Office Suite. You should also be able to work independently and as...


  • Pittsburgh, Pennsylvania, United States Synectics Inc Full time

    **Job Overview**Synectics Inc is a leading company in the healthcare industry, offering a wide range of services to its clients. We are currently seeking a highly skilled and motivated Biological Specimen Processing Specialist to join our team.Salary: $45,000 - $55,000 per year, depending on experience. This role offers a competitive salary, comprehensive...


  • Pittsburgh, Pennsylvania, United States NTT DATA Full time

    We are currently seeking a qualified Healthcare Data Processing Clerk to join our team at NTT DATA. This is a temporary assignment that may last 3 months or longer.About the PositionIn this role, you will be responsible for performing daily tasks such as processing and distributing inbound non-production and outbound mail, accurately handling and entering...


  • Pittsburgh, Pennsylvania, United States System One Full time

    As a Senior Business Process Specialist at System One, you will play a key role in driving the Commercial Lending Platform Modernization project forward.Job SummaryThis is a 12+ month contract position with opportunities for extension and potential conversion to a full-time role. The ideal candidate will be local or willing to relocate within commuting...


  • Pittsburgh, Pennsylvania, United States PNC Full time

    Company OverviewPNC, a leading financial institution, is committed to delivering exceptional customer experiences. We strive to create an inclusive workplace culture where all employees feel valued and empowered to contribute to our success.Job Description:We are seeking a Strategic Business Process Consultant to join our Retail Lending Solutions Platform...


  • Pittsburgh, Pennsylvania, United States Vesuvius Full time

    Job DescriptionWe are seeking a highly skilled Process Innovation Manager to join our team at Vesuvius, a global leader in molten metal flow engineering and technology.The successful candidate will have a strong background in materials science and engineering, with a focus on steel-making and refractory materials. Key responsibilities include:Developing and...


  • Pittsburgh, Pennsylvania, United States AMETEK, Inc. Full time

    At AMETEK Process Instruments, we focus on developing innovative analyzers that enhance productivity and quality in various industries. Our team of experts continuously seeks ways to overcome the limitations of current process monitoring, control, and quality assurance methods.We are seeking an Analytical Applications Scientist to join our team and support...


  • Pittsburgh, Pennsylvania, United States Vimerse InfoTech Inc Full time

    About Vimerse InfoTech Inc">We're a dynamic company that values innovation and teamwork. As a Scrum Master at Vimerse InfoTech Inc, you'll play a critical role in driving project success and fostering a collaborative environment.">Job Overview:">This position involves facilitating Agile processes, managing stakeholders, and leading cross-functional teams. If...


  • Pittsburgh, Pennsylvania, United States Highmark Health Full time

    **Job Overview:**As a Lead Quantitative Researcher at Highmark Health, you will be responsible for leading the development of advanced analytics solutions to drive business growth and improve operational efficiency.**Key Responsibilities:**Design and implement complex analytical models to predict outcomes and optimize business processesLead cross-functional...