Manager, Quality Operations, R&D Quality Assurance

Alcon

$121K — $157K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree or equivalent experience
  • Fluent in English
  • 5 years of relevant experience
  • Experience in medical device or regulated industry preferred
  • Ability to communicate effectively in a team environment

Responsibilities

  • Design and deploy Quality Systems for R&D instrumentation
  • Implement quality assurance strategies and drive compliance
  • Manage project timelines and resource allocation
  • Ensure accurate documentation per design plans
  • Revise Standard Operating Procedures as necessary
  • Oversee R&D compliance in product development
  • Maintain rigorous quality control and training adherence

Benefits

  • Health and life insurance coverage
  • Retirement plan options
  • Flexible time off for salaried associates
  • Paid time off for hourly associates
  • Career growth opportunities in a collaborative environment
Full Job Description
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.
  • Individual Contributor


WHAT YOU'LL BRING TO ALCON:
  • 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
  • Work Hours: Monday - Friday, 8:00 AM - 5:00 PM CST
  • Location: Onsite
  • Travel Requirements: Up to 10%
  • Relocation Assistance: None
  • Sponsorship Available: No


PREFERRED:
  • Medical Device or other regulated industry


HOW YOU CAN THRIVE AT ALCON:
  • Collaborate with teammates to share standard processes and learnings as work evolves!
  • Join Alcon's mission to provide top-tier, innovative products and solutions to enhance sight & enhance lives.
  • Grow your career in a highly collaborative and diverse environment.
  • Alcon provides robust benefits package including health, life, retirement, flexible time off for salaried associates, paid time off for hourly associates and much more!


Alcon Careers

See your impact at alcon.com/careers

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Compensation and Benefits

Alcon's Total Rewards programs are designed to align incentives with business objectives, support our values, and deliver long-term value. Our compensation approach includes a combination of fixed and variable pay, with short-term and long-term incentive opportunities for eligible roles. Our benefits offerings are designed to support associates and their families across key life events, including programs that promote health and well-being, provide financial security, and support retirement planning.

The salary range posted represents the anticipated hiring range for this role. Actual compensation may vary based on factors such as experience, skills, location, and internal equity, and may fall outside the posted range.

Pay Range
121,550.00 - 157,300.00

Pay Frequency
Annual

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