Senior Quality Engineer I – Complaints

Alcon USA

Sinking Spring, PA


At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Senior Quality Engineer I supporting **Quality Assurance, **you will be trusted to work on developing, modifying, applying, and maintaining quality evaluation and control systems/protocols at Sinking Spring, PA, USA.

The Senior Quality Engineer I is responsible for working with the Quality Operations, Quality Manufacturing, and MS&T Engineering teams to support activities during the overall product life cycle of the assigned product groups. The Sr. QE I will lead complaint investigations and support continuous improvement projects, quality issue resolution, Non-conformances/CAPAs, process controls, and validations.

In this role, a typical day will include:
  • Investigate customer complaints to determine the root cause
  • Maintain knowledge of product quality controls and failure modes
  • Uses various statistical and non-statistical problem-solving tools as part of the analysis of data, issues, or improvement opportunities
  • Contribute to the continued alignment of local, global, and industry standards/regulations including cGMPs & ISO standards
  • Support the reduction of recurring nonconformance events
  • Provide Progress Reports and trending to show product quality levels and respond to regulatory requests and critical issue events
  • Provide complaint trending analyses to support the improvement of products manufactured in the facility and prepare trend reports for the site Complaint Review Board and Post Product Risk Activities.
  • Actively participate and contribute to routine platform-based meetings and change control activities
  • Identify and Support improvement efforts within the complaint-handling process
  • Provide day-to-day mentoring, assistance, and support to Complaint Department QE/s, QE Techs
  • Perform quality approval on SOPs, specifications, preventative maintenance, and training documents
  • Complete GAP analysis against local, global, and industry standards, as needed, and lead or support development/execution of actions to close gaps
WHAT YOU'LL BRING TO ALCON:
  • Bachelor’s Degree or equivalent years of directly related experience (or high school +10 yrs.; Assoc.+6 yrs.; M.S.+0 yrs.)
  • The ability to fluently read, write, understand, and communicate in English
  • 2 Years of Relevant Experience
  • Relocation assistance/Sponsorship available: No
PREFERRED QUALIFICATIONS, SKILLS, & EXPERIENCE
  • Advanced Project Management knowledge
  • Knowledge of iTrack and SAP
HOW YOU CAN THRIVE AT ALCON:
  • See your career like never before with focused growth and development opportunities
  • Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
  • Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

__PRESENT

You should be proficient in:

  • Bachelor's Degree
  • Basic Computer Skills
  • Engineering Degree
  • Excellent Communication Skills
  • Experience in a Manufacturing Environment
  • Project Management
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