Quality Intelligence

Alcon Indonesia; Batam; On-site; IDR 100.000.000 - 200.000.000; Full time

Job summary

A global leader in eye health is looking for a Sr. Associate in Quality Assurance Engineering in Batam, Indonesia. This role requires a Bachelor's degree in Science or Engineering and a minimum of 5 years of experience, including 2 in the medical or pharmaceutical sector. Responsibilities include managing quality evaluations, leading investigations, and ensuring product integrity through statistical analysis. Ideal candidates will be thorough, analytical, and able to work effectively in a team environment. Opportunities for growth and international exposure are available.

Benefits

Opportunities for career growth

Exposure to global projects

Qualifications

• Minimum 5 years of experience in relevant field, with at least 2 years in medical or pharmaceutical industry.
• Strong understanding of CAPA and ISO 13485.
• Proven track record of leading complex complaints in regulated environments.

Responsibilities

• Develop and maintain quality evaluation and control systems.
• Lead investigations to identify root causes and establish corrective actions.
• Review Quality documentation as assigned.
• Analyze data/metrics using sound statistical practices.

Skills

Quality assurance

Statistical analysis

Complaint investigations

CAPA knowledge

Team collaboration

Education

Bachelor’s degree in Science or Engineering

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 Engineering function, a team focused on improving quality, processes, products, packaging and materials across our business to help deliver brilliant outcomes. The Sr. Associate, Quality Assurance Engineering, is primarily responsible for developing, modifying, and maintaining quality evaluation and control systems, devising inspection methods, and managing product quality risks. You will apply advanced technical knowledge and analytical skills to ensure product precision and reliability.

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

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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With worldwide headquarters in Atlanta, Ciba Vision is a global leader in the research, development and manufacturing of optical and ophthalmic products and services, including contact lenses and lens care products. Ciba Vision products are available in more than 70 countries worldwide.