Quality Engineer II

Quality Engineer II

Full-time

Company Description

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss.

Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts.

Job Description

The Quality Engineer II establishes and maintains systems to support the overall quality system for manufacturing of products.

Define the quality needs during the development and commercialization of products and their processes using design and development systems in accordance with FDA and international regulations.

MAJOR DUTIES OF POSITION

• Maintain the quality system for InnFocus, Inc. in compliance with the with ISO 13485, the U.S. Code of Federal Regulations, the European Medical Device Directive, the Canadian Medical Device Regulation, and other designated country regulations.
• Manage and maintain various electronic and paper-based Quality Systems, such as nonconformances, CAPAs, deviations, reworks, and other systems as needed.
• Represent Quality during Material Review Board meetings as required.
• Lead the Design Control activities required during design and development and design change processes e.g., design plans, quality plans, component / subassembly / final product test requirements and quality testing procedures.
• Generate, modify as needed, and follow approved procedures such as Standard Operating Procedures, Quality Procedures, Work Instructions, etc.

for activities conducted.

• Apply appropriate problem-solving techniques for effective root cause analysis and successful corrective action.
• Implement validation protocols / reports for existing and new equipment, test method validations, process and product performance qualifications.
• Ensure records i.e. test reports, evaluations, protocol reports, etc. are created and maintained in accordance with requirements of InnFocus Standard Operating Procedures.
• Monitor and intercede in the quality system activities to assure compliance.
• Other quality assurance activities as needed in support of the quality management system.
• Maintain effective communications with supervisor and peers in daily activities.

Qualifications

KNOWLEDGE AND SKILL REQUIREMENTS :

• Four-year degree in sciences or engineering or equivalent experience.
• Minimum of three years of previous experience in quality control or quality assurance in a medical device environment.
• Strong computer skills, advanced Excel, and ability to learn new softwares quickly.
• Statiscal techniques and Minitab experience is a plus.
• A CQE certification is a plus.

PHYSICAL REQUIREMENTS :

• Capable of lifting at least 50 lb of weight.
• Able to work in an industrial environment.

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments.

We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment.

At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members.

All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin / ancestry, religion, sexual orientation, gender, gender identity / expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

COVID-19 Vaccination Requirement : Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19.

Individuals who choose not to get vaccinated and who receive a job offer must follow Santen’s process for requesting a medical or religious exemption and subsequent accommodation.

Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Santen.

All your information will be kept confidential according to EEO guidelines.

For more information about our company and the work experience, please visit and .