Manager, Quality Operations, R&D Quality Assurance

Alcon Research•Lake Forest, CA

6d•Onsite

About The Position

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Manager, Research & Development Quality Assurance is primarily responsible for designing, deploying, and monitoring Quality Systems within Alcon Instrumentation R&D. You will handle training, change control, non-conformances, investigations, Corrective and Preventive Actions (CAPAs), supplier management, audits, document control, and compliance at our Facility in Lake Forest, CA. Specifics Include: Manage individual projects, applying advanced knowledge to achieve objectives and enhance project performance and operational efficiency. Develop and implement quality assurance strategies, ensuring compliance with industry standards and drive continuous improvement. Make operational decisions for projects, managing resources and timelines. Assure accurate and appropriate supporting documentation according to a defined design plan. Identify and contribute to revisions of Standard Operating Procedures. Ensure compliance of all Research and Development (R&D) activities within product development and direct R&D personnel to execute appropriately. Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Commit to compliance with regulatory requirements and continuous improvement in operations. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Requirements

Bachelor’s Degree or equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
The ability to fluently read, write, understand and communicate in English
5 Years of Relevant Experience

Nice To Haves

Medical Device or other regulated industry

Responsibilities

Manage individual projects, applying advanced knowledge to achieve objectives and enhance project performance and operational efficiency.
Develop and implement quality assurance strategies, ensuring compliance with industry standards and drive continuous improvement.
Make operational decisions for projects, managing resources and timelines.
Assure accurate and appropriate supporting documentation according to a defined design plan.
Identify and contribute to revisions of Standard Operating Procedures.
Ensure compliance of all Research and Development (R&D) activities within product development and direct R&D personnel to execute appropriately.
Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
Commit to compliance with regulatory requirements and continuous improvement in operations.