QA Staff Engineer

at  Thermo Fisher Scientific

Paisley, Scotland, United Kingdom - 00000

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate15 Aug, 2021Not Specified15 May, 2021N/APharmaceutical Industry,Agile,Software,Trackwise,Access,Biomedical Engineering,Oversight,Outlook,Interpersonal Skills,Risk Analysis,Iso,Black Belt,Rca,CollaborationNoNo
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Description:

ABOUT US:

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com

Who we are looking for? – skills, experience and abilities

  • Bachelor’s degree from accredited college/university or equivalent experience with a preference for Science, Engineering, or specialty Biomedical Engineering.
  • Significant experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products.
  • Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions and to partner with and influence key stakeholders
  • Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency. Lean Six Sigma Black Belt or trained in Lean Sigma/Six Sigma processes.
  • Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
  • Expert knowledge of quality standards (e.g., 21 CFR Part 820, ISO 13485, MDSAP, excipient manufacturing regulations) and Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective.
  • Compliance with quality standards ((e.g., 21 CFR Part 820, ISO 13485, 9001)
  • Quality tools e.g. FMEA, Risk Analysis, RCA
  • Global Systems e.g. TrackWise, AGILE, E1/SAP, LIMS
  • Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.)

Responsibilities:

  • As a Quality Lead for site and network complex projects you will be ensuring compliance is considered through all project phases, generate Quality plans, Lead Risk Assessments and Change controls.
  • Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency. EPM trained and experienced facilitator for PPI activities.
  • Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
  • Lead QA initiatives to maintain and improve site QMS and compliance to ISO 13485, ISO 14971, 21 CFR Part 820 and IVDR.
  • Subject matter expert in technical and facility requirements including standards and specifications for cleanrooms, Water Systems.
  • Quality oversight for validation plans and IQ/OQ/PQ reviews.
  • Support Data Integrity programme
  • Support site Quality Management System driving effective Complaint Handling, CAPA system, Change Control, Internal Auditing, Quality Training, and Manufacturing Area Support.
  • Ensure the Quality Management System requirements are established and maintained, and the performance of the QMS is reviewed with Management.
  • Host customer technical visits and customer audits
  • Quality Expert and advisor for supporting functions and support shop floor quality improvement activities
  • Lead and facilitate escalated quality investigations utilizing effective problem solving and root cause analysis tools to drive robust CAPA plans

Who we are looking for? – skills, experience and abilities

  • Bachelor’s degree from accredited college/university or equivalent experience with a preference for Science, Engineering, or specialty Biomedical Engineering.
  • Significant experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products.
  • Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions and to partner with and influence key stakeholders
  • Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency. Lean Six Sigma Black Belt or trained in Lean Sigma/Six Sigma processes.
  • Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
  • Expert knowledge of quality standards (e.g., 21 CFR Part 820, ISO 13485, MDSAP, excipient manufacturing regulations) and Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective.
  • Compliance with quality standards ((e.g., 21 CFR Part 820, ISO 13485, 9001)
  • Quality tools e.g. FMEA, Risk Analysis, RCA
  • Global Systems e.g. TrackWise, AGILE, E1/SAP, LIMS
  • Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.).


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Production / Maintenance / Quality

Clinical Pharmacy

Graduate

Engineering

Proficient

1

Paisley, United Kingdom