At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
This position is responsible for ensuring the design transfer and manufacturing operation activities of medical devices produced 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.
In this role, a typical day will include:
- 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.
- Provide e-compliance oversight to site CSV activities.
- 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 to Alcon, QMS and Safety requirements.
- Performs any other duties as assigned by Supervisor according to business needs.
What You'll Bring to Alcon
- Degree in Engineering field
- 2-3 years of experience in Quality Assurance ; exp in Pharmaceutical and Medical Device industry will be highly advantageous but not a MUST
- Strong process knowledge/ Good knowledge of cGMPs, ISO13485, 21 CFR Part 11 and/ or ISO9001 requirements.
- Knowledge of Change Control, Document Control, Training Systems and/ or Non conformance systems will be of added advantage.
How You Can Thrive
- Join a global leader with a rich history of innovation and excellence in eye care.
- Be part of a collaborative and supportive team culture that values diversity and inclusion.
- Enjoy a competitive compensation package and opportunities for career advancement.
- Make a meaningful difference in the lives of patients worldwide by contributing to cutting-edge advancements in eye health.
At Alcon, we empower our people to make a difference while growing their careers in an exciting and supportive environment. Join us and see brilliance in every opportunity!
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