Quality Systems Engineer
Novartis - Duluth, GA

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Building on its heritage of more than 65 years, Alcon, the global leader in eye care, is the second largest division of the Novartis Group with combined pro-forma sales of more than USD 9.4 billion in 2010. The division was formed by Novartis on April 8, 2011, following the closing of the merger between Alcon and Novartis. The new Alcon Division combines the product portfolios, commercialization capabilities, R&D and talent of Alcon, CIBA VISION and Novartis Ophthalmics. Today, Alcon has more than 22,000 employees with headquarters in Fort Worth, Texas, U.S.A. Alcon's three businesses - Surgical, Pharmaceutical and Vision Care - meet the diverse needs of eye care professionals and patients offering the widest spectrum of eye care products with operations in 75 countries and products available in 180 markets.

Alcon currently has an opening for a Quality Systems Engineer in Johns Creek, Georgia.

The Quality Systems Engineer will lead and support activities during and product transfer and overall product life cycle of the LightStream 3 (LS3) production platform. The QSE will support the Quality System integration, process control documentation and oversee of product and process validations.

Major Accountabilities include:
Interacts effectively with other global Vision Care manufacturing facilities to support product transfer

Assure compliance with site Quality Systems procedures

Provides guidance and facilitate risk management reviews (HA, FTA, FMEA, ISO 14971)

Review and support validations for laboratories, product, equipment and manufacturing processes

Assure there are adequate product and process controls in place for identified CTQ's

Review and approval of change control and validation documentation

Identifies and drives continuous quality improvement opportunities

Conducts failure investigation and implement preventive and corrective actions

Uses various statistical and non-statistical problem-solving tools as part of analysis

Able to travel abroad, primarily Germany, potentially for extended periods of time
B.S. Engineering or Physical Sciences (e.g. Chemistry, Physics, etc.)

  • 5+ yrs Quality Engineering experience in regulated industry for Medical Device or Pharmaceuticals
  • Experience in manufacturing quality (packaging, formulation, critical systems, automation, etc.).
  • Thorough knowledge of cGMP and ISO regulations.
  • Experience in FMEA, Control Plans, MSA and CTQ's process capability
  • Understanding of LEAN and six sigma principles.
  • Process transfer, scale-up and process improvement experience
  • Project management experience.
  • Ability to communicate in German a plus
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Novartis - 3 years ago - save job
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Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...