Associate I, Quality Operations

Alcon; Sinking Spring (Berks County); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Paid time off

Job summary

Alcon is seeking an Associate I, Quality Operations to help monitor product quality, resolve non-conformances, and maintain documentation. You will apply advanced quality management practices and conduct independent research.

In this role you will support product validations, enable product tech transfer, and collaborate with Manufacturing, Engineering, and suppliers on root-cause analysis and corrective actions. Travel 5-10% and on-site work are required.

Qualifications

• Bachelor's degree in Engineering or related field
• Experience with medical devices or pharmaceuticals
• Proficiency in Excel, PowerPoint, and Minitab
• Strong analytical and communication skills

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 product and process controls for identified quality attributes in production areas
• Investigate NCs, CAPA, and provide guidance
• Work with suppliers on root cause analysis and corrective actions
• Lead product holds and quarantine when necessary
• Assist Manufacturing, Engineering and other Quality functions on the production floor
• Support and promote improvements in production areas
• Administer validation protocols for product/process changes and write final technical summaries

Skills

Excel

PowerPoint

Minitab

Analytical skills

Communication skills

Team collaboration

Education

Bachelor's degree in Engineering

Tools

Minitab

Excel

PowerPoint

Job description

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.

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 problemsolving skills
• Ability to work collaboratively in a fastpaced, regulated environment
• Interest in quality systems, manufacturing processes, and continuous improvement

HOW YOU CAN THRIVE AT ALCON:

• Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Collaborate with teammates to share standard processes and findings as work evolves!
• See your career like never before with focused growth and development opportunities!
• Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.