Associate I, Quality Operations

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.

WHAT YOU'LL BRING TO ALCON:

• 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

PREFERRED QUALIFICATIONS, SKILLS, & EXPERIENCE

• 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