Quality Engineer II

AlconSinking Spring, PA
1dOnsite

About The Position

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Associate II, Quality Assurance is primarily responsible for handling complex quality assurance tasks, ensuring effective quality control and compliance, and managing Quality Systems, Complaints, and Supplier Quality Management processes. You’ll use strong attention to detail and communication skills to support compliance and continuous improvement at our Manufacturing facility in Sinking Spring, PA. Specifics Include:

Requirements

  • Bachelor’s Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
  • The ability to fluently read, write, understand and communicate in English

Nice To Haves

  • SAP knowledge
  • ASQ CQE Certification preferred
  • Project Management knowledge
  • Statistics (including sampling) knowledge

Responsibilities

  • Ensure compliance with current Good Manufacturing Practice (cGMP), Health Authority, Alcon Quality Manual requirements, and International Organization for Standardization (ISO) standards
  • Work with the Quality and Manufacturing teams to support activities during the overall product life cycle of the assigned production area(s)
  • Investigate and/or provide input on non-conformance events (NC) and Corrective Actions and Preventive Actions (CAPA)
  • Promote the reduction of recurring nonconformance events, reprocessing events, and scrap
  • Perform quality approval on SOP's, specifications, preventative maintenance, calibration, and training documents
  • Provide QE support for process validations
  • Manage product holds and quarantine and support Escalation events
  • Lead, support and promote improvement activities for the site
  • Own / support change control process
  • Support internal & external audits
  • Complete GAP analysis against local, global, and industry standards

Benefits

  • Alcon provides robust benefits package including health, life, retirement, flexible time off for salaried associates, paid time off for hourly associates and much more!
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service