Quality Engineer
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.
As an Quality Engineer you are tasked to 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 at Tuas. 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
- Review and approve validation protocols and reports; ensure compliance with established procedures andsound 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
- Bachelor/ Degree in Science, Life Science, Engineering or other appropriate education and
- experience in pharmaceutical and medical device industry
- 1-3 years of experience in Quality Assurance or Quality Control in a Pharmaceutical and
- Medical Device
- Have good knowledge of cGMPs, ISO13485, 21 CFR Part 11 and/ or ISO9001
- Have experience in validation activities.
- Knowledge of Change Control, Document Control, Training Systems and/or Non-conformance systems will be of added advantage.
- Must be able to work independently and have good decision making ability and interpersonal skill.
- Must have strong communication skills, ability to work within and/or lead a team, with good problem solving skill.
Why Join Us:
- Opportunity to work with a leading global medical device company.
- Collaborate with a diverse and talented team in a supportive work environment.
- Competitive compensation package and comprehensive benefits.
- Continuous learning and development opportunities.
%20PTE.%20LTD..png)
