Associate I, Quality Operations

Alcon • Sinking Spring, PA

17h • Onsite

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 I, Quality Operations is primarily responsible for applying specialized knowledge to support project goals by monitoring product quality, resolving non-conformances, and maintaining documentation. You will use advanced quality management practices and conduct independent research. 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 areas. 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 areas. 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.

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
• Work hours: Exempt
• Work Location: Onsite
• Travel Requirements: 5-10%
• Relocation assistance: None
• Sponsorship available: No

Nice To Haves

• Bachelor’s degree in Engineering (e.g., Mechanical, Industrial, Biomedical, or related field) preferred, recent graduates are encouraged to apply
• Experience with medical devices or pharmaceuticals
• Knowledge of Excel, Power Point and Minitab
• Strong analytical, communication, and problem‑solving skills
• Ability to work collaboratively in a fast‑paced, regulated environment
• Interest in quality systems, manufacturing processes, and continuous improvement

Responsibilities

• 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 areas.
• 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 areas.
• 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.

Benefits

• Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1-10 employees