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!

Alcon Careers

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Total Rewards

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 through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness.  To learn more about Alcon’s Corporate Social Responsibility including our Total Rewards, click here

Pay Range

$126,240.00 - $189,360.00

Pay Frequency

Annual

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [email protected] and let us know the nature of your request and your contact information.