Senior Quality Chemical Engineer

COMPANY DESCRIPTION

In 2016, InnFocus was purchased by Santen Pharmaceutical Co., Ltd., a Japanese pharmaceutical company, specializing in ophthalmology and rheumatology medicines. With its ophthalmic products Santen holds the top share within the Japanese market and is one of the leading ophthalmic companies worldwide, with its products being sold in over 50 countries.

With the passionate support of our Japanese parent company and its 125-year heritage, Santen in collaboration with InnFocus is pursuing intellectually-challenging and stimulating work to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss.

The Company's scientists and engineers are global leaders in the development of highly biocompatible biomaterials and medical devices. The InnFocus MicroShunt® Glaucoma Drainage System (formerly known as the "MIDI Arrow") is the first of what the Company expects to be many medical devices that incorporate these materials in the eye. It was developed in collaboration with the University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute.

We are driven by and committed to our mission: Delivering Vision, Every Day. Additionally, our Corporate Strategy Policy for FY18-FY20 has provided essential focus for new commercialization efforts that will be fueled through an unprecedented increase in marketing investment and talent acquisition across Marketing, Sales, and R&D teams.

We are in search of top talent to help us meet our aggressive and important goals.General Purpose of Position: 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.

Duties and Responsibilities:

1. 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.
2. Determine the quality needs during the design and development process, e.g., the establishment of validation master plans, quality plans, component/subassembly/final product test requirements and quality testing procedures.
3. Generate validation and test protocols and reports.
4. Conduct testing of product as needed.
5. Establish validation master plans and quality plans for products.
6. Generate, modify as needed, and follow approved procedures such as GOPs, OPSs, QLPs, etc. for activities conducted.
7. Maintain working knowledge of U.S. Quality System Regulations, ISO 13485, MDD and CMDR.
8. Assure individual and group safety when conducting all activities.
9. Maintain effective communications with supervisor and peers in daily activities.
10. Act as the Quality representative on product development teams and material review boards as needed.
11. Implement validation protocols / reports for existing and new equipment, test method validations, process and product performance qualifications.
12. Ensure records i.e. test reports, evaluations, protocol reports, etc. are created and maintained in accordance with requirements of InnFocus Standard Operating Procedures.
13. Apply appropriate problem-solving techniques for effective root cause analysis and successful corrective action.
14. Monitor and intercede in the quality system activities to assure compliance.
15. Provide education to employees on QSR, ISO 13485, MDD, CMDR and other applicable regulations and standards.
16. Other quality assurance activities as needed in support of the quality management system.

Knowledge and Skills Required:

1. Four-year degree in chemical engineering or equivalent.
2. Minimum of five years of previous experience in quality control or quality assurance in a medical device environment.
3. A CQE certification is a plus.