Engineer II, QA

Thermo Fisher Scientific-posted 3 months ago
Full-time • Entry Level
Marietta, OH
5,001-10,000 employees
Computer and Electronic Product Manufacturing
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As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

  • Join Thermo Fisher Scientific's Quality Assurance team and make a difference in a global, dynamic organization.
  • Ensure flawless quality and compliance, supporting our mission to drive growth and innovation.
  • Knowledge of Regulatory and Quality system requirements (ISO 13485:2016).
  • Foster a collaborative relationship with Operations to promote a culture of ongoing education on the Quality Management System.
  • Facilitate and participate in Customer / Internal audits.
  • Apply problem-solving skills related to quality issues to ensure timely resolution with minimal impact.
  • Embrace site PPI initiatives and adopt this methodology in day-to-day tasks.
  • Take charge of plant-wide initiatives for addressing and preventing issues, with a key focus on handling customer returns and identifying root causes.
  • Serve as a manufacturing liaison during new product development.
  • Provide Quality mentorship for product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs.
  • High school diploma or equivalent experience required.
  • Bachelor's degree or equivalent experience preferred; applicable experience will be considered.
  • 3 years' experience in Quality systems based in ISO 13485:2016 and 21 CFR 820 preferred.
  • Strong analytical and problem-solving skills.
  • Effective communication skills across all organizational levels.
  • Strong technical writing abilities and familiarity with software applications like MS Office or similar, SAP, Salesforce.
  • Capable to prioritize in a fast-paced manufacturing organization.
  • Manufacturing environment desired.
  • Mastery in conducting investigations and root cause analysis for complaints, non-conforming products, and CAPAs.
  • Competitive remuneration.
  • Annual incentive plan bonus.
  • Healthcare.
  • Range of employee benefits.
  • Outstanding career and development prospects.
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