Quality EngineerThis position is responsible for ensuring the design transfer and manufacturing operation activities of medical devices produced to meet the requirements of Alcon standards, 21 CFR Part 820, Part 11, ISO 13485, the Medical Device Regulation (MDR), and other applicable regulations and standards. This position supports both Program Management and Operations through all phases of our medical products' lifecycle, these activities include but are not limited to, validation, nonconformance, customer complaints, risk assessment, and support maintenance of the QMS.Key Accountabilities:
- Provide operational support for product release to ensure it meets all quality and regulatory requirements when necessary.
- Conduct and support investigations for non-conformances, FAAs, and customer complaints.
- Review and approve validation protocols and reports; ensure compliance with established procedures and sound validation methodology.
- Review and approve manufacturing operational activities, such as nonconformance, CAPA, escalation, and customer complaints.
- Provide quality oversight to activities related to calibration, preventive maintenance, spare part assessment, and associated deviations.
- Support internal and external audits and is responsible for audit finding closure, as required.
- Work with cross-functional teams to resolve operational quality issues
- Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/management as necessary
- Identify improvement opportunities and lead/support the implementation activities to improve performance and efficiency.
- Meet quality objectives set by management & comply with Alcon, QMS, and Safety requirements.
- Performs any other duties as assigned by Supervisor according to business needs.
Education:
- Bachelor's degree; Engineering/ Science Discipline.
Experience:
- At least 2 years of working experience in GMP environment, familiar with ISO 13485 requirements is preferred.
- Preferably with validation process background.
- Experience with quality assurance will be advantageous.
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What We Do
Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning more than seven decades, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 20,000 associates are enhancing the quality of life through innovative products, partnerships with eye care professionals and programs that advance access to quality eye care.
