Quality Intelligence

3 days ago

Batam, Indonesia Alcon Full time

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?

We are seeking a highly experienced and technically proficient Control Automation Principal Engineer to lead the design, implementation, and optimization of automation systems within our medical device manufacturing operations, and in compliance with regulatory standards (e.g., FDA, GMP). This role requires a blend of deep technical expertise, strategic thinking, and strong leadership to drive innovation, ensure operational excellence, lead cross-functional project teams, and driving digital transformation initiatives.

Specifics Include:

- Supports and at times, leads and manages post-market VOC/investigations to identify root causes, establishes corrective actions and executes prevention plans in products and/or processes (both internal and external)
- Establishes corrective actions for deviations, provides formal structured approach to assist in determining root cause for nonconforming events and evaluate CAPAs for lifecycle effectiveness
- Reviews Deviations, Investigations, Impact Assessments and other forms of Quality documentation as assigned
- Assure timely completion of CAPA items
- Proficient in process, product, and data review within respective field of operation in accordance with job responsibility and function, able to troubleshoot process, material and technique-related issues
- Works with Quality Organization to collect Voice of Customers and understand non-conforming events
- Works with the Supplier Quality Organization to mine, analyze data and drive root cause analysis and corrective actions that will help eliminate supplier related quality issues
- Analyzes data/metrics using sound statistical practices. Develops and implements solutions based on statistical analysis
- Researches and writes special investigations technical summary. Reacts quickly to trends and issues detected by quality intelligence data and effectively addresses them.
- Ability to travel domestically and internationally as needed.

WHAT YOU’LL BRING TO ALCON:

- Bachelor’s degree in Science or Engineering.
- Minimum 5 years of experience in the relevant field, with at least 2 years in the medical or pharmaceutical industry.
- Deep knowledge of complaint investigations and analysis.
- Strong understanding of CAPA and ISO 13485
- Proven track record of leading complex complaints in regulated environments.

HOW YOU CAN THRIVE AT ALCON:

- Good team player
- Part of growing company
- Opportunity be involved and exposure to projects from global site

ATTENTION: Current Alcon Employee/Contingent Worker

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