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Senior Quality Engineer

Employer
Santen, Inc.
Location
Miami, FL
Start date
Oct 28, 2021

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Discipline
Engineering, Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

Job Details

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. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL). 

We are in search of top talent to help us meet our important goals and large growth plans.

ABOUT THE POSITION

The Senior Quality Engineer will 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. Establish and maintain systems to support the overall quality system for manufacturing of products.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

  • Maintain the quality system for InnFocus, Inc. in compliance 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. 
  • Maintain Risk Management File for the MicroShunt and represent Quality during Risk Management activities by developing and maintaining FMEAs, Risk Assessments, and Risk Management Reports, etc. 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 validation and test protocols and reports. 
  • Conduct testing of product as needed. 
  • 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. 
  • Assure individual and group safety when conducting all activities. 
  • Maintain effective communications with supervisor and peers in daily activities. 
  • Act as the Quality representative on product development teams and material review boards as needed. 
  • 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. 
  • Provide education to employees on QSR, ISO 13485, MDD, CMDR and other applicable regulations and standards. 
  • Other quality assurance activities as needed in support of the quality management system.

QUALIFICATIONS:

  • Bachelor’s Degree or equivalent experience plus minimum 7+ years experience in quality control or quality assurance. May consider equivalent combination of education and experience.
  • Knowledge of QA, Regulatory/Quality Compliance in the medical device industry.
  • Able to utilize computers for development of reports and summary of project experience.
  • Strong proficiency with MS Office tools to include Word, Excel, PowerPoint and Outlook.
  • 5+ years medical device manufacturing environment experience preferred
  • Knowledge of inspection equipment is required. As a minimum, experience with calipers, micrometers, pin gauges, and optical measurement systems or similar equipment. 
  • Position requires innovative thinking, ability to solve problems and meet deadlines.
  • Strong cross-functional communication skills with ability to liaise throughout all levels of the organization.
  • A CQE certification is a plus. 

Location:

  • Miami, FL

COVID-19 Vaccination Requirement: Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19 unless a medical or religious accommodation is timely requested and approved. 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.

For more information about our company and the work experience, please visit www.santenusa.com and https://www.santenusa.com/career-culture

Company

Santen is a global pharmaceutical and medical device company focused solely on ophthalmology. We’re committed to serving serious unmet needs by developing innovative solutions that protect vision and, in turn, preserve quality of life for people around the world.

Santen USA, located in Emeryville, CA, is an important part of our ophthalmic research, development, and commercialization efforts worldwide and the home of our regional business teams. By leveraging our deep industry knowledge and a network of external partners, we aim to deliver game-changing therapies and make hope a reality for people facing vision impairment and loss.

Our deep roots start in Japan, Santen’s worldwide headquarters, where the company began in 1890. Since then, Santen has become an established leader in the Asian and European prescription ophthalmology marketplaces and continues to expand across global markets, including the United States. Today, Santen employs more than 4,000 people worldwide and sells specialty ophthalmic products in more than 60 countries.

With a clear focus on vision, we aim to deliver the highest quality products, to act with integrity, to earn the trust of our partners and customers, and to deliver sight-saving innovations to physicians and patients who are waiting for them.
 

 

Company info
Website
Location
6401 Hollis Street
Emeryville, CA 94608
United States

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