Quality Engineer I

at  Alcon

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 Quality Engineer I supporting Quality Ops & DHR, you will be trusted to work on supporting activities during the overall product life cycle of the assigned production area(s). The Quality Engineer I will also support continuous improvement projects, quality issue resolution, non-conformances/CAPAs, and process control. In some cases, the Quality Engineer I will be required to lead small to medium size projects at Sinking Spring, PA.

In this role, a typical day will include:

• Interact effectively with other facilities to support product tech transfer
• Support product validations through data collection
• Support/ execute validations, product, equipment, and manufacturing processes
• Ensure adequate product and process controls are in place for identified critical or major quality attributes/process parameters within assigned production area(s)
• Investigate and/or provide input on non-conformance events(NC), Corrective Actions, and Preventive Actions (CAPA) while providing guidance and approval
• Ensure supplier-related quality issues (i.e. customer complaints, non-conformances) with assigned commodities are corrected to prevent recurrence. Partner with the supplier on the use of root cause analysis tools paired with a formal corrective action process
• Ensures immediate action, including for cause visits, is taken with suppliers on issues deemed critical
• Track and trend NC and CAPA data with guidance using various statistical and non-statistical problem-solving tools as part of the analysis
• Lead product holds and quarantine when necessary
• Assist Manufacturing, Engineering, and other Quality functions to create a presence on the production floor to support the production process
• Support and promote improvement activities for production area(s)
• Uses various statistical and non-statistical problem-solving tools to analyze data, issues, or improvement opportunities
• Administer validation protocols associated with product/process changes including writing the initial protocol for qualification, scheduling the logistics of the protocol run with manufacturing, product testing, and evaluation writing a final technical summary to include conclusions drawn from the test data and subsequent recommendations

PREFERRED QUALIFICATIONS, SKILLS, & EXPERIENCE

• Engineering Degree preferred
• Experience with medical devices or pharmaceuticals
• Knowledge of Excel, Power Point and Minitab

• Interact effectively with other facilities to support product tech transfer
• Support product validations through data collection
• Support/ execute validations, product, equipment, and manufacturing processes
• Ensure adequate product and process controls are in place for identified critical or major quality attributes/process parameters within assigned production area(s)
• Investigate and/or provide input on non-conformance events(NC), Corrective Actions, and Preventive Actions (CAPA) while providing guidance and approval
• Ensure supplier-related quality issues (i.e. customer complaints, non-conformances) with assigned commodities are corrected to prevent recurrence. Partner with the supplier on the use of root cause analysis tools paired with a formal corrective action process
• Ensures immediate action, including for cause visits, is taken with suppliers on issues deemed critical
• Track and trend NC and CAPA data with guidance using various statistical and non-statistical problem-solving tools as part of the analysis
• Lead product holds and quarantine when necessary
• Assist Manufacturing, Engineering, and other Quality functions to create a presence on the production floor to support the production process
• Support and promote improvement activities for production area(s)
• Uses various statistical and non-statistical problem-solving tools to analyze data, issues, or improvement opportunities
• Administer validation protocols associated with product/process changes including writing the initial protocol for qualification, scheduling the logistics of the protocol run with manufacturing, product testing, and evaluation writing a final technical summary to include conclusions drawn from the test data and subsequent recommendation