Alcon

Eye care products and vision solutions

Quality Engineer

Quality Engineering +1Confirmed live in the last 24 hours

Full-timeBatam, Batam City, Riau Islands, IndonesiaNo salary listedIn-person

About the Job

Requirements

A bachelor's degree in Engineering or a Science-related field is required.
One to two years of relevant work experience is preferred.
Experience handling non-conformance investigations, root cause analysis, and corrective and preventive actions.
Experience supporting validation and qualification activities for products, processes, raw materials, and/or computerized systems.
Strong communication and stakeholder management skills are required.
Good verbal and written communication skills in English are required.

Responsibilities

Assist with, execute, or lead non-conformance investigations, root cause analysis, and the generation and execution of corrective and preventive actions.
Review and execute engineering studies and validation and qualification activities for new or existing products, processes, raw materials, and computer systems.
Perform risk assessments for products, processes, and systems.
Support or lead change requests for product or process improvements.
Conduct periodic quality oversight in the operations area.
Communicate product-quality issues, dispositions of non-conforming products, and escalations.
Support and participate in the Compliance Improvement Program.
Work with manufacturing to implement process improvements.
Assess and determine the direct or indirect GxP applicability of systems.
Conduct periodic quality oversight of computerized systems in the operations area.
Ensure compliance with lifecycle requirements for computerized systems and their data.
Review, execute, and approve validation and qualification activities for new or existing computerized systems.
Ensure compliance and provide guidance and technical support to QA, Manufacturing, MST, and Engineering.
Work in accordance with the HSE manual and documented procedures, and report HSE issues.
Leverage good practices by referencing other Alcon sites.
Review historical quality performance, including non-conformance, customer complaint, and escalation data, from other Alcon sites.

Desired Qualifications

One to two years of relevant work experience is preferred.

• Assist/Execute/Lead Non-Conformance Investigation, RCA, and the generation/execution of CAPA.

• Review/execute engineering studies/validation/qualification activities for new/existing product/process/raw material/computer systems.

• Perform risk assessment for product/process and system.

• Support/lead Change Request for any product/process improvement.

• Conduct quality oversight at the operation area on a periodic basis.

• Communicate issues related to product quality, disposition of non-conforming products & escalations.

• Support and involved in Compliance Improvement Program.

• Work with manufacturing to implement process improvements.

• Perform assessment, determines GxP applicability (Direct/Indirect impact) of the system.

• Conduct quality oversight for the computerized systems at the operation area on a periodic basis.

• Ensure compliance with lifecycle requirement for Computerized System and its data.

• Review/Execute/Approve validation/qualification activities for new/existing computerized systems.

• Ensure compliance and provide guidance plus technical support to QA/Manufacturing/MST& Engineering.

• Work in-accordance with HSE manual and documented procedures, and reporting HSE issues.

• Leveraging good practices by referencing other Alcon sites.

• Review historical quality performance (non-conformance, customer complaint, escalation) from other Alcon sites.

Qualifications:

• Bachelor's degree in Engineering or a Science-related field.

• 1-2 years of relevant work experience are preferred.

• Experience handling Non-Conformance investigations, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA).

• Experience supporting validation and qualification activities for products, processes, raw materials, and/or computerized systems.

• Strong communication and stakeholder management skills.

• Good verbal and written communication skills in English.

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About the Company

Alcon

Eye care products and vision solutions

Alcon provides eye care products and vision solutions to improve how people see. It develops and manufactures devices and consumables for eye health, including cataract surgery equipment and intraocular lenses, retinal health therapies, and contact lenses, distributed through eye care professionals, hospitals, and consumers. The products work by supporting eye surgery, protecting and restoring vision, or correcting vision with lens-based options, backed by research and development and a global distribution network. Alcon differentiates itself with a broad, end-to-end portfolio across the eye care continuum, a strong emphasis on research and development, strategic partnerships with healthcare providers, and a commitment to diversity and inclusion. Its goal is to enhance vision and quality of life by delivering reliable, high-quality eye care solutions and advancing the science of eye health.

Company size: 10,001+
Company stage: IPO
Headquarters: Geneva, Switzerland
Founded: 1945

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