QA Manager / Director

Company Description

Advanced Vision Science, Inc. (AVS), (a wholly owned subsidiary of Santen Pharmaceutical Co., Ltd) is a medical device company with a global presence seeking a QA Manager or Director. 

Our core businesses are research and development and the manufacturing of implantable medical devices including intraocular lenses and lens materials for cataract treatment. When you work with AVS, you will have the opportunity to develop advanced next-generation surgical products and implantable devices to contribute to improving the lives of patients worldwide. Nearly half of the world's blindness is attributed to cataracts, an opacification of the natural crystalline lens. Intraocular lenses are used for the treatment of cataract patients by replacing the natural crystalline lens.

The role is on site.

Job Description

The QA Manager / Director will be responsible for managing all activities of the Quality Assurance department and maintaining the Company's Quality Management System in accordance with applicable international standards and regulatory requirements.

Managing the QA team and sharing supervisory responsibility of one employee in Logistics and carrying out supervisory responsibilities in accordance with AVS' policies and applicable laws. 

Furthermore:

• Establish and maintain the AVS Quality Management System (QMS), ensuring ongoing compliance with applicable domestic and international quality assurance for AVS’ medical device design, manufacture, and distribution. 

• Manage the Company's QMS, including QA Inspection, Document Control, Medical Device Post-Market Vigilance and Complaint Handling and Evaluation, Risk Management processes (ISO 13485 and 14971 Standards), Corrective/Preventive Action, Environmental Monitoring, and Equipment Calibration processes

• Support applicable improvements to the QMS and appropriate integration of processes into Santen corporate systems. 

• Support Santen Global Teams for improvement of Global Medical Device policies, standard operating procedures, and systems to the extent possible. 

• Establish and maintain product inspection, acceptance or rejection and release activities, including ensuring there are adequate numbers of qualified employees in these Departments. 

• Assist in the development of domestic or international regulatory filings and act as liaison with Santen Ltd. and Santen Inc. Quality, Regulatory, and R&D groups where requested. 

• Actively participate in the AVS management team and provide leadership in Quality for the Production and R&D departments.   

• Interact, create and maintain quality, laboratory, or service agreements (as appropriate) with vendors, suppliers, subcontractors, and consultants as defined by established procedures and applicable regulations or standards with a customer serving face.

• Other duties may be assigned. 

Qualifications

• What you will bring to the role

• Bachelor's degree (B.A. /Sc.) from four-year college or university 
• At least 7 years’ related experience in QA in a medical device manufacturing environment
• Knowledge of the ISO 13485 Quality Management Standard & FDA medical device regulations.
• Must be detailed oriented and able to multi-task 
• Excellent verbal and written communication skills 
• Must be dependable and flexible 
• Must be a team player and have experience providing support for numerous internal customers  
• PHYSICAL DEMANDS: 
• Varied sitting, standing and walking
• Ability to lift and carry 50lbs. or less

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.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.

What we offer:

The salary range for the QA Manager position is $110 - $130,000 depending on experience.
The salary range for the QA Director position is $120,000 - $170,000 depending on experience.

Would you like to learn more about this position. Apply now.