A global eye care leader, CIBA VISION has one of the most exciting product pipelines in the industry today. A pipeline of innovative contact lenses and lens care products brought to life by diverse, talented, performance driven people who share a passion for healthy vision and better life. All of which makes us one of the most rewarding employers in our field.

How do you spend your day? Are you passionate about what you do? At CIBA VISION, our focus is clear, our purpose defined. We are part of a team that is making a difference in the quality of people’s lives.

Think what’s possible.

The major purpose of this position is to lead and execute the necessary activities within product development teams to achieve project quality objectives, especially those relating to effective design controls, design reviews, and design transfers in order to assure the following:

 Product Safety & Efficacy and Process Capability & Reliability

 All elements of the Product Quality System are in place and functional

 Project is in compliance with the company's Policies, Procedures and Standards

 All product development operations are in compliance with Health Authority GXP regulations and standards

Primary Responsibilities:
1. Engineering and Leadership
* Apply engineering concepts to develop practical solutions for product quality issues within product development
* Apply engineering and statistical concepts for Quality Plans, Statistical justifications and rationale and analysis of validation results

2. Systems Development
* Support and actively implement the development and continuous improvement of product development policies, procedures, processes and instructions
* Implement existing and new federal (GMP) and international quality systems, regulatory and statutory requirements into the CIBA VISION’s Product Development Process
* Translate design control regulations into action plans and practical advice that facilitate product development business compliance

3. Product Development Team Support
* Actively participate in and/or facilitate the development of product deliverables required for compliance (i.e, development plans, design reviews, quality plans, design transfer, design verification/ validation, statistical plans, and rationale for design control activities/requirements, design history file.)

* Implement Design of Experiments and Problem Analysis/Solving concepts within R,D & E

* Direct all activities necessary

for the project team to achieve design control deliverables, specifically deliverables related to product safety and performance

* Actively partner with the project teams to facilitate the incorporation of all quality system elements, root cause analysis, corrective action and continuous improvement principles throughout the entire development process

4. Systems Compliance
* Actively participate in and/or facilitate internal/external audits of the product development process, analysis & closure to corrective and preventative actions
* Active involvment in the development of validation protocols and reports; specifically sections that define requirements for validation approval

As a CIBA VISION associate, you are expected to know, understand, and comply with all applicable safety and health standards and rules.

CIBA VISION is an equal opportunity employer M/F/D/V.Minimum Education Required:
 B.S in Engineering, Science or Statistics
Preferred Level:
 Masters in Quality, Engineering, Sciences or Statistics

Minimum Experience Required:
 A minimum of 7 years of collective experience in product development and quality in a medical device environment.
 A minimum of 3 years developing and continuously improving lean, efficient and effective product development processes
Preferred Level:
 Experience with new product and new process development
 Direct FDA interactions, e.g. NDA, PMA, 510(k) submission and/or new product/process inspection leader

Minimum Skills Required:
 Medical device GxP & ISO Standards proficiency
 Product/process/system validations – demonstrated proficiency
 FMEA, QFD – demonstrated proficiency
 Problem analysis – demonstrated proficiency
 Risk analysis/assessments – demonstrated proficiency
 Statistical proficiency
 Interpersonal skills
 Leadership skills
Preferred Level:
 Certified Six Sigma Black Belt
 Design of Experiments
 Design for Six Sigma