Quality Engineer
As a Quality Engineer you will plan, conduct and provide direction on all quality engineering activities. You will coordinate and direct activities of quality engineers and other quality engineering staff, and be responsible for the development of assigned staff.
Responsibilities
Utilize Quality Engineering principles and problem‑solving skills to improve and maintain products/processes aligned with the overall quality and business vision, ensuring production build schedule attainment.
Lead and manage investigations, providing a formal structured approach to identify root causes, establish corrective actions and execute prevention plans in products and/or processes.
Employ risk management to prevent unanticipated failure modes and improve process capability.
Develop effective quality strategies for validation of equipment, test methods and processes, including master validation plans and risk management documentation in accordance with regulatory and Alcon requirements.
Apply Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
Review analytical methods and specifications, validation protocols, deviations, investigations, impact assessments and other quality documentation as assigned.
Qualifications
2+ years of experience in a relevant role.
Knowledge of FDA, medical device, GMP and validation requirements.
Experience in equipment and process validations.
Knowledge of statistics.
Project management, problem solving, statistical analysis and word‑processing skills.
People management experience.
Strong report‑writing skills and highly developed people skills, including coaching and performance management.
Diploma in business, science or engineering.
Benefits
Competitive salary package with fixed salary, bonus, pension and health insurance.
Flexible work environment with competent and committed colleagues and a respectful workplace.
Focused growth and development opportunities.
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