Sr. Manager, R&D QA

Summary:

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 a Sr. Manager, R&D QA, you will be responsible for strategic and tactical execution for all aspects of quality related to design and development of surgical ophthalmic instrumentation devices in alignment with R&D QA and Surgical R&D goals. You will drive the implementation of the quality system for new development products/processes, post-market improvements, and lifecycle management, ensuring successful implementation of design control and risk management processes, and transfer to Manufacturing. The role will be located at the Lake Forest (Main Campus), CA US facility.

In this role, typical activities will include:

• Facilitating technical or personnel issues, leads process issues to drive resolution; identifies areas of opportunities; makes timely decisions with minimal direction
• Setting tactical direction for direct reports to align with functional goals
• Developing associates to be competent and skilled in the technical and functional aspects of their role
• Supporting strategic initiatives and directs associates for adoption
• Participating in operational and management reviews
• Assuring the R&D policies, procedures, standards and systems are current and comply with all applicable Corporate policies, Health/ Regulatory Authority requirements, and are at least equal to industry best practices. Determines strategic need for QAAs and assures execution
• Hosting internal audits and possibly external audits; establishes annual plan for self-assessments assuring strategically important areas are inspected and ISO 13485 elements are appropriately addressed; assures observations are relevant to improve area systematically and reviews/approves final reports
• Preparing and providing budget information for own team
• Applying expertise in quality standards, including ISO 13485, 21CFR820 and associated product / process standards.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree (eg. Biomedical Engineering, Mechanical Engineering, Electrical Engineering or other technically related engineering degree) or Equivalent years of directly related experience  
• The ability to fluently read, write, understand and communicate in English
• 7 Years of Relevant Experience
• Must be authorized to work for any employer in the United States

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Work hours: Exempt

Travel Requirements: 0-10%

Relocation assistance: Yes

Sponsorship available: No

PREFERRED QUALIFICATIONS / SKILLS / EXPERIENCE:

• Advanced statistical knowledge and strong interpersonal skills.
• Expert in Design Control, Risk Management and Validation

HOW YOU CAN THRIVE AT ALCON:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Collaborate with teammates to share standard processes and findings as work evolves!
• See your career like never before with focused growth and development opportunities!
• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

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Alcon’s Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value.  The first layer of our rewards program is compensation.  We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population.  Our benefits program provides security for life events t